FDA.reportPublic FDA data

Benadryl

Product NDC
85237-1960
11-digit product format
852371960
Labeler code
85237
Product ID
85237-1960_55d102a9-ee25-98b4-e063-6294a90a90dc
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Select Consumer Group
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-09-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Benadryl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup
1049632Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55d10292-e673-9896-e063-6294a90a5674Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 152 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Black Cherry Cough DropsMENTHOLBoston Nutraceutical Production SL856f2e1a-2593-99e6-e053-2991aa0ad0392024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857363b6-e025-e074-e053-2a91aa0a43792024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857365ba-895e-4a63-e053-2991aa0a8b9f2024-10-07WarningsExact identifier
application number: M012
Menthol Vapor Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.La7062db1-8201-b400-e053-2a95a90a55e82024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SLb8f48a47-6871-f7ed-e053-2995a90a16f32024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SL856f0bd8-354b-a002-e053-2a91aa0a80222024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SL83c4928a-eea6-e176-e053-2991aa0a6bb12024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.Lc2340f56-9a8e-4eea-e053-2995a90a78fc2024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.La706ee9c-9ed0-d3f1-e053-2a95a90a26d62024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff0b37b-6c08-b687-e053-2a95a90a11a92024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLCefcf2edd-21a3-45f9-e053-2995a90a38652024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff65505-8846-35c2-e053-2a95a90a6b792024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLCeff0fdfe-695a-4e62-e053-2a95a90ab50f2024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff1a70f-fa71-52b2-e053-2995a90a038c2024-10-07WarningsExact identifier
application number: M012
Honey Lemon Menthol Cough DropsHONEY LEMON MENTHOLTopco Associates LLCf5be283b-524d-26af-e053-2995a90a39722024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff16ba3-7e30-aa93-e053-2995a90a64cb2024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.ebf6bcf5-9384-052a-e053-2a95a90a30a52024-10-07WarningsExact identifier
application number: M012
Rompe Pecho SF Flu SF FluBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06eac696-e8f6-ac50-e063-6394a90a2ed62024-10-07WarningsExact identifier
application number: M012
dg health nasal fourPHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCceeeb016-8e46-40b8-9923-8a4270475f452024-10-04WarningsExact identifier
application number: M012
Topcare Nasal FourPHENYLEPHRINE HYDROCHLORIDETopco Associates LLC99bc8829-167b-4cf8-8421-57da369f24cd2024-10-04WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-1960-1852371960011 POUCH in 1 BLISTER PACK (85237-1960-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) 1 pouch2012-06-04NoNoCurrent
85237-1960-2852371960022 POUCH in 1 BLISTER PACK (85237-1960-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) 2 pouch2012-06-04NoNoCurrent
85237-1960-38523719600320 POUCH in 1 CARTON (85237-1960-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) 20 pouch2012-06-04NoNoCurrent
85237-1960-48523719600425 POUCH in 1 CARTON (85237-1960-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) 25 pouch2012-06-04NoNoCurrent
85237-1960-58523719600530 POUCH in 1 CARTON (85237-1960-5) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) 30 pouch2012-06-04NoNoCurrent
85237-1960-7852371960073 POUCH in 1 BLISTER PACK (85237-1960-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-1960-0) 3 pouch2025-06-04NoNoCurrent