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 145 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacyd40d6fd1-3f84-40ae-ab7e-04569eb416172024-10-30WarningsExact identifier
application number: M012
equaline nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI4e0c6ad6-81ef-4b0e-b2eb-44256faf73582024-10-30WarningsExact identifier
application number: M012
GOOD REMEDIES Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fbe2c0-7749-4c8a-e063-6394a90a7c6e2024-10-30WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC130e68d1-9048-49c1-beee-490eecaed2d92024-10-30WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company02f3e739-3153-412f-b2cd-6f01dcd5875b2024-10-30WarningsExact identifier
application number: M012
HealthWise Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcare25a19d3e-37b3-50d5-e063-6394a90a97d12024-10-29WarningsExact identifier
application number: M012
Antigrip FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC25a23a03-6110-f595-e063-6394a90a70fe2024-10-29WarningsExact identifier
application number: M012
Antigrip Cough and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC25a23e5e-302a-7b7f-e063-6294a90a04632024-10-29WarningsExact identifier
application number: M012
Antigrip Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLPharmadel LLC25a26adf-fd90-bf57-e063-6294a90a40732024-10-29WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.Le82dac83-2910-44dc-e053-2995a90a38e12024-10-29WarningsExact identifier
application number: M012
TheraCare Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcared6e789c7-a55a-dc9a-e053-2a95a90a2bdb2024-10-29WarningsExact identifier
application number: M012
Careone daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAmerican Sales Company31187c98-6706-4962-91f6-022a390cda392024-10-28WarningsExact identifier
application number: M012
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC0100f86e-257f-4197-9849-3c4429cdf0f22024-10-28WarningsExact identifier
application number: M012
Premier Value Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINPHARMACY VALUE ALLIANCE LLC46bf124a-a44f-4066-b936-852d46da8f402024-10-28WarningsExact identifier
application number: M012
Signature Care Non drowsy Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway25a26577-a9f8-49cb-9d75-d8c471e4aaf62024-10-28WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e2024-10-28WarningsExact identifier
application number: M012
Leader Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leaderd38537c6-9553-4e93-a83e-11ed48c955ab2024-10-28WarningsExact identifier
application number: M012
Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy2b3a1997-f382-4843-a44b-d80d1ad21a902024-10-28WarningsExact identifier
application number: M012
Premier Value Tussin Cough Long ActingDEXTROMETHORPHAN HBRChain Drug Consortium, LLC0e393287-5bb8-458b-98c4-55fa16674d062024-10-28WarningsExact identifier
application number: M012
daytime cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.1740ccfc-6e68-46f4-a1ba-48fe092f0aa02024-10-28WarningsExact 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