FDA.reportPublic FDA data

Berkley and Jensen Allergy Relief

Product NDC
68391-200
11-digit product format
683910200
Labeler code
68391
Product ID
68391-200_a8ab9724-9b0a-4e3b-b31e-97f0ecb7cceb
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
BJWC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-12-10
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
Berkley and Jensen Allergy Relief
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 · 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
b52fc311-8853-4116-941b-8be35456abbaAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68391-200-792024-01-30C16284748780-11030e365-44da-111a-e063-dadaa90a10e2BJWC Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-200-79Berkley and Jensen Allergy Relief400 in 1 BOTTLETABLET4006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MBERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPBERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-200BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]6Current NDC, Legacy NDC, 1 package rows20240720_b52fc311-8853-4116-941b-8be35456abba.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 95 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care OriginalOXYMETAZOLINE HYDROCHLORIDESAFEWAY, INC.f7ad687b-dcaf-928c-e053-6294a90a6abe2025-10-16WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)90ccb29c-9967-46cb-a409-e440344e1a1a2025-10-15WarningsExact identifier
application number: M012
Robitussin Childrens Honey Day Night DM Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCf9999875-3433-4052-a628-39539d3732162025-10-15WarningsExact identifier
application number: M012
Robitussin Day and Night Cough Relief Value PackDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATEHaleon US Holdings LLC4029eccd-5443-4ae2-9232-2a1d922798f82025-10-15WarningsExact identifier
application number: M012
EndaCof DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.c68ea55a-8b9a-4a70-8b5c-1a27366518132025-10-15WarningsExact identifier
application number: M012
DURATUSS DMDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.413a3951-d704-f14b-e063-6394a90a06dc2025-10-15WarningsExact identifier
application number: M012
LoHist DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.29730dab-fa09-4351-9b36-0359ba4f77442025-10-15WarningsExact identifier
application number: M012
M-END DMXDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDER. A. McNeil Companyee1fae2e-3a21-4487-9989-c7620a4a70562025-10-15WarningsExact identifier
application number: M012
Chlo TussCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDER.A. McNeil Company43610aaa-8b94-40d5-ae09-3d75bd2317c82025-10-15WarningsExact identifier
application number: M012
Chlo HistCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATER. A. McNeil Companyd046f4ba-5753-4ed5-a924-0b66fd1167812025-10-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)6ca7372b-50c4-4b15-b133-fefa35525ade2025-10-15WarningsExact identifier
application number: M012
Extra Strength Sinus Relief Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH0d8a009c-30b5-4f12-90bd-f8aa1110243f2025-10-14WarningsExact identifier
application number: M012
Tussin DM Cough plus Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCardinal Health 110, Inc. DBA LEADER9d11f443-c93d-44e8-b5a3-2677b7b112122025-10-14WarningsExact identifier
application number: M012
Rompe Pecho SFGUAIFENESINEfficient Laboratories, Inc.31ff48fc-9603-413c-ab7c-2598b3e08f9c2025-10-14WarningsExact identifier
application number: M012
Rompe Pecho DMDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Incd108c712-bc36-41d7-9ccd-720496b5599e2025-10-14WarningsExact identifier
application number: M012
Rompe Pechito DM for KidsDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc004d12e1-6e3d-84c8-e063-6394a90aa6532025-10-14WarningsExact identifier
application number: M012
VANACOF CP Allergy / CoughCHLOPHEDIANOL HCL, PYRILAMINE MALEATEGM Pharmaceuticals, INC0bdea30a-39da-6611-e063-6394a90aa4cf2025-10-14WarningsExact identifier
application number: M012
VANACOFCHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDEGM Pharmaceuticals, INCcf3886ab-62b3-497a-a587-18cbfbaf36342025-10-14WarningsExact identifier
application number: M012
Sugar Free Cherry Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.42d4bafb-b630-487e-b63d-13ad37a594542025-10-14WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc410c19f7-213d-cd99-e063-6294a90af5a32025-10-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNb52fc311-8853-4116-941b-8be35456abba6
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDb52fc311-8853-4116-941b-8be35456abba6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-200-7968391020079400 TABLET in 1 BOTTLE (68391-200-79) 400 tablet2013-12-100000-00-00NoNoCurrent