Source documents
Every FDA label behind this catalog
Every factual section of every medication page on this site is built from one of the documents below. They are listed newest first, because the age of a label is worth knowing before opening it.
- Labels
- 57
- Prescription
- 48
- Over the counter
- 9
- With a boxed warning
- 12
| Label | What it approves | FDA application | This version | Document |
|---|---|---|---|---|
| Ozempic injectionSEMAGLUTIDEBoxed warning | What it approvesType 2 diabetes, with cardiovascular and kidney indicationsPrescription | FDA applicationNDA209637 | This version30 July 2026version 1 | DocumentDailyMed |
| FoundayoORFORGLIPRONBoxed warning | What it approvesWeight managementPrescription | FDA applicationNDA220934 | This version29 July 2026version 10 | DocumentDailyMed |
| AimovigERENUMAB-AOOE | What it approvesPreventive treatment of migrainePrescription | FDA applicationBLA761077 | This version14 July 2026version 25 | DocumentDailyMed |
| RhofadeOXYMETAZOLINE HYDROCHLORIDE | What it approvesPersistent facial redness of rosaceaPrescription | FDA applicationNDA208552 | This version13 July 2026version 3 | DocumentDailyMed |
| TrulicityDULAGLUTIDEBoxed warning | What it approvesType 2 diabetes, and cardiovascular risk in heart diseasePrescription | FDA applicationBLA125469 | This version16 June 2026version 62 | DocumentDailyMed |
| Famotidine tabletsFAMOTIDINE | What it approvesUlcers, GERD, erosive esophagitisPrescription | FDA applicationANDA216441 | This version11 June 2026version 3 | DocumentDailyMed |
| AjovyFREMANEZUMAB-VFRM | What it approvesPreventive treatment of migrainePrescription | FDA applicationBLA761089 | This version5 June 2026version 24 | DocumentDailyMed |
| EmgalityGALCANEZUMAB-GNLM | What it approvesPreventive treatment of migraine, and episodic cluster headachePrescription | FDA applicationBLA761063 | This version5 June 2026version 17 | DocumentDailyMed |
| Nurtec ODTRIMEGEPANT SULFATE | What it approvesAcute treatment of migraine, and prevention of episodic migrainePrescription | FDA applicationNDA212728 | This version4 June 2026version 32 | DocumentDailyMed |
| FarxigaDAPAGLIFLOZIN | What it approvesType 2 diabetes, heart failure, chronic kidney diseasePrescription | FDA applicationNDA202293 | This version3 June 2026version 47 | DocumentDailyMed |
| LomairaPHENTERMINE HYDROCHLORIDE | What it approvesWeight reduction, short term onlyPrescription | FDA applicationANDA203495 | This version21 May 2026version 3 | DocumentDailyMed |
| Metformin hydrochlorideMETFORMIN HYDROCHLORIDEBoxed warning | What it approvesType 2 diabetesPrescription | FDA applicationANDA077095 | This version19 May 2026version 14 | DocumentDailyMed |
| ProtonixPANTOPRAZOLE SODIUM | What it approvesErosive esophagitis in GERDPrescription | FDA applicationNDA020987 | This version18 May 2026version 48 | DocumentDailyMed |
| ZepboundTIRZEPATIDEBoxed warning | What it approvesWeight management, and obstructive sleep apnea in obesityPrescription | FDA applicationNDA217806 | This version22 April 2026version 38 | DocumentDailyMed |
| QsymiaPHENTERMINE AND TOPIRAMATE | What it approvesLong-term weight managementPrescription | FDA applicationNDA022580 | This version22 April 2026version 42 | DocumentDailyMed |
| MounjaroTIRZEPATIDEBoxed warning | What it approvesType 2 diabetesPrescription | FDA applicationNDA215866 | This version22 April 2026version 38 | DocumentDailyMed |
| ProscarFINASTERIDE | What it approvesEnlarged prostatePrescription | FDA applicationNDA020180 | This version18 March 2026version 9 | DocumentDailyMed |
| AlliORLISTAT | What it approvesWeight loss aidOver the counter | FDA applicationNDA021887 | This version18 March 2026version 15 | DocumentDailyMed |
| Nizoral A-D shampooKETOCONAZOLE | What it approvesDandruffOver the counter | FDA applicationNDA020310 | This version17 March 2026version 7 | DocumentDailyMed |
| SaxendaLIRAGLUTIDEBoxed warning | What it approvesWeight managementPrescription | FDA applicationNDA206321 | This version25 February 2026version 22 | DocumentDailyMed |
| RenovaTRETINOIN | What it approvesFine facial wrinklesPrescription | FDA applicationNDA021108 | This version24 February 2026version 14 | DocumentDailyMed |
| Doryx MPCDOXYCYCLINE HYCLATE | What it approvesBacterial infectionsPrescription | FDA applicationNDA050795 | This version16 February 2026version 15 | DocumentDailyMed |
| Isotretinoin capsulesISOTRETINOINBoxed warning | What it approvesSevere nodular acnePrescription | FDA applicationANDA212333 | This version13 February 2026version 4 | DocumentDailyMed |
| Pepcid ACFAMOTIDINE | What it approvesRelieving and preventing heartburnOver the counter | FDA applicationNDA020325 | This version6 February 2026version 20 | DocumentDailyMed |
| Rybelsus and Ozempic tabletsORAL SEMAGLUTIDEBoxed warning | What it approvesType 2 diabetesPrescription | FDA applicationNDA213051 | This version30 January 2026version 13 | DocumentDailyMed |
| JardianceEMPAGLIFLOZIN | What it approvesType 2 diabetes, heart failure, chronic kidney diseasePrescription | FDA applicationNDA204629 | This version30 January 2026version 31 | DocumentDailyMed |
| MaxaltRIZATRIPTAN BENZOATE | What it approvesAcute treatment of migrainePrescription | FDA applicationNDA020864 | This version29 January 2026version 4 | DocumentDailyMed |
| XenicalORLISTAT | What it approvesObesity managementPrescription | FDA applicationNDA020766 | This version9 January 2026version 10 | DocumentDailyMed |
| NexiumESOMEPRAZOLE MAGNESIUM | What it approvesGERD, erosive esophagitis, ulcersPrescription | FDA applicationNDA022101 | This version19 December 2025version 74 | DocumentDailyMed |
| Imitrex tabletsSUMATRIPTAN | What it approvesAcute treatment of migrainePrescription | FDA applicationNDA020132 | This version9 December 2025version 24 | DocumentDailyMed |
| AldactoneSPIRONOLACTONE | What it approvesHeart failure, hypertension, edema, hyperaldosteronismPrescription | FDA applicationNDA012151 | This version28 November 2025version 25 | DocumentDailyMed |
| ContraveNALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDEBoxed warning | What it approvesLong-term weight managementPrescription | FDA applicationNDA200063 | This version10 November 2025version 27 | DocumentDailyMed |
| VictozaLIRAGLUTIDEBoxed warning | What it approvesType 2 diabetesPrescription | FDA applicationNDA022341 | This version14 October 2025version 31 | DocumentDailyMed |
| Prilosec OTCOMEPRAZOLE MAGNESIUM | What it approvesFrequent heartburn, as a 14-day courseOver the counter | FDA applicationNDA021229 | This version1 October 2025version 17 | DocumentDailyMed |
| QuliptaATOGEPANT | What it approvesPreventive treatment of migrainePrescription | FDA applicationNDA215206 | This version30 September 2025version 19 | DocumentDailyMed |
| Metronidazole topical gelMETRONIDAZOLE TOPICAL | What it approvesPapules and pustules of rosaceaPrescription | FDA applicationANDA077547 | This version12 September 2025version 2 | DocumentDailyMed |
| Retin-A MicroTRETINOIN | What it approvesAcne vulgarisPrescription | FDA applicationNDA020475 | This version1 September 2025version 23 | DocumentDailyMed |
| Clindamycin and benzoyl peroxide gelCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | What it approvesAcne vulgarisPrescription | FDA applicationNDA050819 | This version15 August 2025version 6 | DocumentDailyMed |
| EpsolayBENZOYL PEROXIDE | What it approvesInflammatory lesions of rosaceaPrescription | FDA applicationNDA214510 | This version11 August 2025version 2 | DocumentDailyMed |
| Phentermine hydrochloridePHENTERMINE HYDROCHLORIDE | What it approvesWeight reduction, short term onlyPrescription | FDA applicationANDA040526 | This version14 July 2025version 10 | DocumentDailyMed |
| PrevacidLANSOPRAZOLE | What it approvesGERD, erosive esophagitis, ulcersPrescription | FDA applicationNDA020406 | This version8 July 2025version 45 | DocumentDailyMed |
| Prevacid 24 HRLANSOPRAZOLE | What it approvesFrequent heartburn, as a 14-day courseOver the counter | FDA applicationANDA202319 | This version24 June 2025version 3 | DocumentDailyMed |
| UbrelvyUBROGEPANT | What it approvesAcute treatment of migrainePrescription | FDA applicationNDA211765 | This version5 June 2025version 27 | DocumentDailyMed |
| CabtreoCLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE | What it approvesAcne in patients 12 and olderPrescription | FDA applicationNDA216632 | This version24 April 2025version 6 | DocumentDailyMed |
| OraceaDOXYCYCLINE | What it approvesInflammatory lesions of rosaceaPrescription | FDA applicationNDA050805 | This version16 April 2025version 23 | DocumentDailyMed |
| AvodartDUTASTERIDE | What it approvesEnlarged prostatePrescription | FDA applicationNDA021319 | This version12 March 2025version 4 | DocumentDailyMed |
| Omeprazole delayed-release capsulesOMEPRAZOLE | What it approvesGERD, erosive esophagitis, ulcersPrescription | FDA applicationANDA204012 | This version9 January 2025version 2 | DocumentDailyMed |
| WinleviCLASCOTERONE | What it approvesAcne in patients 12 and olderPrescription | FDA applicationNDA213433 | This version2 January 2025version 8 | DocumentDailyMed |
| JanuviaSITAGLIPTIN | What it approvesType 2 diabetesPrescription | FDA applicationNDA021995 | This version14 November 2024version 71 | DocumentDailyMed |
| Women's RogaineMINOXIDIL | What it approvesHair regrowth on the scalp, womenOver the counter | FDA applicationNDA021812 | This version13 November 2024version 6 | DocumentDailyMed |
| SoolantraIVERMECTIN | What it approvesInflammatory lesions of rosaceaPrescription | FDA applicationNDA206255 | This version24 October 2024version 8 | DocumentDailyMed |
| PropeciaFINASTERIDE | What it approvesMale pattern hair loss, in men onlyPrescription | FDA applicationNDA020788 | This version14 October 2024version 9 | DocumentDailyMed |
| AkliefTRIFAROTENE | What it approvesAcne in patients 9 and olderPrescription | FDA applicationNDA211527 | This version16 September 2024version 7 | DocumentDailyMed |
| Men's Rogaine Extra StrengthMINOXIDIL | What it approvesHair regrowth on the scalp, menOver the counter | FDA applicationNDA020834 | This version6 September 2024version 5 | DocumentDailyMed |
| WegovySEMAGLUTIDEBoxed warning | What it approvesWeight management, and cardiovascular risk in heart diseasePrescription | FDA applicationNDA215256 | This version23 April 2024version 6 | DocumentDailyMed |
| Nexium 24HRESOMEPRAZOLE MAGNESIUM | What it approvesFrequent heartburn, as a 14-day courseOver the counter | FDA applicationNDA204655 | This version19 March 2024version 30 | DocumentDailyMed |
| Differin gelADAPALENE | What it approvesAcneOver the counter | FDA applicationNDA020380 | This version7 December 2022version 10 | DocumentDailyMed |
What these documents are
A prescription label is the prescribing information: the document a manufacturer files and the FDA approves, setting out what the medication is approved to treat, at what doses, with which warnings. Products sold over the counter carry a shorter Drug Facts label instead, and the two are not built the same way, which is why pages here say which kind they are quoting.
Every prescription label opens with Highlights, a summary the regulator requires, followed by the full text. The two overlap heavily, and the same fact often appears twice in different words. Pages on this site remove that repetition and keep the fuller wording.
How to read the columns
An application number beginning with NDA is a new drug application: the original approval, with its own clinical evidence. One beginning with ANDA is an abbreviated application, which is how generics are approved against an existing product. The number is the stable identifier of the approval, while brand names come and go.
The version and date are of the specific document these pages were built from. Labels are revised, and a page built from a superseded version can be wrong, so the date is shown rather than hidden. The newest here is the Ozempic injection label of 30 July 2026; the oldest is Differin gel, 7 December 2022.
A boxed warning is the strongest warning the FDA can require. Where several labels carry the same one, it belongs to the class of medication rather than to the product.
The documents are served by DailyMed and openFDA, both public services of the US National Library of Medicine. This site quotes the sections it names and links to the full document rather than reproducing it. How we source these pages.