FDA.reportPublic FDA data

Allergy Relief

Product NDC
21130-329
11-digit product format
211300329
Labeler code
21130
Product ID
21130-329_61f378b4-cb32-4a07-ad4c-eabb04629ba4
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Better Living Brands, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-02
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage21130-32921130-329-06DDiscontinued by firm2026-10-23
excluded packagepackage21130-32921130-329-12DDiscontinued by firm2026-10-23
excluded packagepackage21130-32921130-329-22DDiscontinued by firm2026-10-23

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
Allergy Relief
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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65802aa7-64e7-4435-ad6b-65895fba17ceAvailable 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
21130-329-06Allergy Relief1 in 1 CARTONTABLET, FILM COATED120
21130-329-06Allergy Relief200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20020
21130-329-08Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1220
21130-329-08Allergy Relief2 in 1 CARTONTABLET, FILM COATED220
21130-329-12Allergy Relief1 in 1 CARTONTABLET, FILM COATED120
21130-329-12Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020
21130-329-22Allergy Relief4 in 1 CARTONTABLET, FILM COATED420
21130-329-22Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1220

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-329ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]19Current NDC, Legacy NDC, 8 package rows20240718_65802aa7-64e7-4435-ad6b-65895fba17ce.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 121 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTIME COLD AND FLUNIGHTIME COLD AND FLUTARGET CORP9dee9b92-eac9-b07d-e053-2995a90a06022025-01-31WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINBryant Ranch Prepack7b23faa9-40c8-4cea-b9fb-487cce2664af2025-01-31WarningsExact identifier
application number: M012
BENADRYL AllergyDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC224ba2a3-1a93-29c8-e063-6394a90a9bef2025-01-30WarningsExact identifier
application number: M012
Extra Strength Nite-Time Pain Relief430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLETWALGREENSc25cff5a-93f5-62aa-e053-2a95a90aa7b42025-01-30WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWALGREENSdbf5c814-4e69-13ac-e053-2a95a90a49a32025-01-30WarningsExact identifier
application number: M012
Mucus DM Fast Max Day Cold and Flu and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWALGREENSf3770976-de73-52b8-e053-2995a90aad4f2025-01-30WarningsExact identifier
application number: M012
Dextromethorphan HBr and Guaifenesin Oral SolutionDEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTIONKESIN PHARMA CORPORATION284eae44-81bc-400c-e063-6394a90af4462025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26c82bc3-5753-4d56-96a4-a3f9c8c267d02025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8095b211-8ae7-44e5-b89a-b7f730e28d512025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2cf2f35b-5d59-e3ff-e063-6294a90a9b452025-01-30WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-Drowsy, DaytimeACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c52025-01-30WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cold and FluACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDERB Health (US) LLC2ce20ab5-5f2d-1c97-e063-6394a90ad67b2025-01-29WarningsExact identifier
application number: M012
Guaifenesin and DextromethorphanGUAIFENESIN AND DEXTROMETHORPHANMajor Pharmaceuticals97b137c9-0bec-409a-91f7-e298c296578b2025-01-29WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINCVS1dc17665-62ce-f7f5-e063-6294a90af8512025-01-29WarningsExact identifier
application number: M012
UP AND UP NO DRIP NASALOXYMETAZOLINE HYDROCHLORIDETarget Corporation760d6d0f-00fc-40bc-858d-83a0827d139f2025-01-29WarningsExact identifier
application number: M012
Guaifenesin and DextromethorphanGUAIFENESIN AND DEXTROMETHORPHANMajor Pharmaceuticals51e48201-bb62-4e89-85eb-e4a416f935222025-01-29WarningsExact identifier
application number: M012
Severe Congestion and Cough MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice8c878e47-94f4-484f-bdd8-6d87ac2440d82025-01-28WarningsExact identifier
application number: M012
Cough and Cold TherapyCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088be461-7afc-586a-e063-6294a90a700b2025-01-27WarningsExact identifier
application number: M012
Cough and Cold Therapy For KidsCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088df369-114c-db4f-e063-6394a90acfac2025-01-27WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a2025-01-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN65802aa7-64e7-4435-ad6b-65895fba17ce20
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD65802aa7-64e7-4435-ad6b-65895fba17ce20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-329-06211300329061 BOTTLE in 1 CARTON (21130-329-06) > 200 TABLET in 1 BOTTLE1 bottle1990-03-020000-00-00NoNoCurrent
21130-329-08211300329082 BLISTER PACK in 1 CARTON (21130-329-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1990-03-020000-00-00NoNoCurrent
21130-329-12211300329121 BOTTLE, PLASTIC in 1 CARTON (21130-329-12) > 100 TABLET in 1 BOTTLE, PLASTIC1990-03-020000-00-00NoNoCurrent
21130-329-22211300329224 BLISTER PACK in 1 CARTON (21130-329-22) > 12 TABLET in 1 BLISTER PACK4 blister pack1990-03-020000-00-00NoNoCurrent