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 firm2026-10-27
excluded packagepackage21130-32921130-329-12DDiscontinued by firm2026-10-27
excluded packagepackage21130-32921130-329-22DDiscontinued by firm2026-10-27

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 161 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIe4f9a846-ab72-4508-b0c5-f7911af2f3d72024-05-23WarningsExact identifier
application number: M012
Adult Cough ReliefDEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c2024-05-20WarningsExact identifier
application number: M012
Chlorpheniramine Maleate 4 mgCHLORPHENIRAMINE MALEATEBryant Ranch Prepack54681242-c861-4415-b5c0-d3ab55b62be12024-05-17WarningsExact identifier
application number: M012
Dibromm Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)c830b18b-4427-4530-9bc7-85c2735080d22024-05-17WarningsExact identifier
application number: M012
Childrens Cold and Cough NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLSafeway, Inc.cbbec807-f882-4c6a-b1cd-c7fd5ce70cad2024-05-15WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.d6ac0d70-0511-4ec8-bb35-8b2e0e3d77422024-05-15WarningsExact identifier
application number: M012
Night Time CoughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.f658a03b-6fc2-4b63-b3ab-7e886fbf20b42024-05-15WarningsExact identifier
application number: M012
AXIV DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINVIVUNT PHARMA LLC18704e66-ee8f-315d-e063-6294a90a52822024-05-14WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.187622dc-ecde-181d-e063-6294a90a4e8f2024-05-14WarningsExact identifier
application number: M012
Lemon Mint DropsMENTHOLTarget Corporation Inc.1876df19-398a-23d8-e063-6394a90ae7e82024-05-14WarningsExact identifier
application number: M012
Cold Flu and Sore Throat Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway, Inc.6c952c81-c8b6-4e74-abd8-781f6f44736b2024-05-14WarningsExact identifier
application number: M012
Pain and Sinus RelieverACETAMINOPHEN AND PHENYLEPHRINEJHK DBA American Safety & First Aid249373c6-f56f-4bd3-9cef-98b7ee73457d2024-05-14WarningsExact identifier
application number: M012
NasalPHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.fea71cb9-e044-4729-ad26-1db0cdb9dd112024-05-14WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.a70ead03-6d2c-44c1-9ae5-f6c4094821ec2024-05-14WarningsExact identifier
application number: M012
Day Time Cold and Flu Relief non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.cc450f89-a156-48e0-82ae-19782f13c2ca2024-05-13WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway, Inc.a8df5c04-0f92-4013-b3e5-2b45009a7b8d2024-05-13WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATESafeway, Inc.f762600a-f4b1-4869-a04b-8431c3d8a3e32024-05-13WarningsExact identifier
application number: M012
Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.ef0cd436-5e81-47a7-92d6-58495283ab282024-05-13WarningsExact identifier
application number: M012
Tussin Cough Sugar FreeDEXTROMETHORPHAN HBR GUAIFENESINP & L Development, LLC7ed2fe86-3346-4308-a9b6-6a264f879b022024-05-09WarningsExact identifier
application number: M012
Severe Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANY10106c90-f2f0-508e-e063-6294a90a544b2024-05-08WarningsExact 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