FDA.reportPublic FDA data

Benadryl Allergy

Product NDC
70264-024
11-digit product format
702640024
Labeler code
70264
Product ID
70264-024_43c8a290-73a2-52bb-e063-6294a90af527
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
R J General Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-01
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
2026-12-31
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 Allergy
Listing expiration
2026-12-31

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
c46c01c0-29f4-400c-bef5-14b3eb944c51Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70264-024-01Benadryl Allergy30 in 1 CARTONTABLET, FILM COATED304
70264-024-01Benadryl Allergy2 in 1 POUCHTABLET, FILM COATED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70264-024BENADRYL ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [R J GENERAL CORPORATION]3Current NDC, Legacy NDC, 2 package rows20241030_c46c01c0-29f4-400c-bef5-14b3eb944c51.zip

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 63 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zicam Extreme Congestion ReliefOXYMETAZOLINE HYDROCHLORIDEChurch & Dwight Co., Inc.ccada339-656c-a461-e053-2a95a90a34792025-12-31WarningsExact identifier
application number: M012
ED A-HIST DMDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.e0e2b117-62bc-4132-9f7c-fe2a912052b12025-12-31WarningsExact identifier
application number: M012
Bio-Z-CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAdvanced Generic Corporation05e70eab-1467-4b09-991e-ef03f222e0212025-12-31WarningsExact identifier
application number: M012
Altipres-BBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAlternative Pharmacal Corporationfd00c41d-0580-4177-afaa-60bb12ca5a092025-12-31WarningsExact identifier
application number: M012
Ninjacof-DCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDECenturion Labs, LLC5188aa20-41f1-4998-81e1-f4de055874bc2025-12-31WarningsExact identifier
application number: M012
Llorens Care Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.4743e562-1217-50ab-e063-6394a90af88d2025-12-31WarningsExact identifier
application number: M012
Llorens Care TussinGUAIFENESINLlorens Pharmaceutical International Division, Inc.474459c1-bfd7-dec7-e063-6394a90ac18d2025-12-31WarningsExact identifier
application number: M012
Geri Care Tussin CF MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINGERI-CARE PHARMACEUTICAL CORP4744669c-7f33-e35f-e063-6394a90a79b72025-12-31WarningsExact identifier
application number: M012
Geri-TussinGUAIFENESINGeri-Care Pharmaceuticals, Corp65545ca3-4e93-4b59-9e17-4742e086e8e72025-12-31WarningsExact identifier
application number: M012
GeriCare Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINGERI-CARE PHARMACEUTICALS, CORP47451cd8-7aab-90e2-e063-6394a90ad1b72025-12-31WarningsExact identifier
application number: M012
Curewell TussinGUAIFENESINRMT HEALTH LLC47455587-5074-e70d-e063-6294a90a78bb2025-12-31WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBestco Inc.77e25027-3c96-21fa-e053-2991aa0a1f312025-12-31WarningsExact identifier
application number: M012
Puregen Labs Allergy ReliefDIPHENHYDRAMINE HCLAdvanced Rx LLC4745d4f9-bbdf-a4a6-e063-6294a90a15b22025-12-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2a46ea9b-29e9-5197-e063-6394a90abc732025-12-31WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLBestco Inc.77e50410-306d-b2fb-e053-2a91aa0af3c52025-12-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONe086a6d2-f664-454e-9524-f656bfbf45df2025-12-31WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLBestco Inc.77f45efb-8ee0-1186-e053-2991aa0a98842025-12-31WarningsExact identifier
application number: M012
Conex PediatricDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a46af43-ef36-e14e-e063-6394a90a82852025-12-31WarningsExact identifier
application number: M012
ConexDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a343656-ac6d-8b20-e063-6294a90ab3192025-12-31WarningsExact identifier
application number: M012
Dologesic NFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division974fc0d5-7a99-46fb-af38-b91240f728fa2025-12-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049632Benadryl 25 MG Oral TabletPSNc46c01c0-29f4-400c-bef5-14b3eb944c514
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNc46c01c0-29f4-400c-bef5-14b3eb944c514
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBDc46c01c0-29f4-400c-bef5-14b3eb944c514
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDc46c01c0-29f4-400c-bef5-14b3eb944c514
1049632Benadryl 25 MG Oral TabletSYc46c01c0-29f4-400c-bef5-14b3eb944c514
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSYc46c01c0-29f4-400c-bef5-14b3eb944c514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70264-024-017026400240130 POUCH in 1 CARTON (70264-024-01) / 2 TABLET, FILM COATED in 1 POUCH30 pouch2022-12-260000-00-00NoNoCurrent