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 6 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HyVee Daytime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc496ec389-1aea-f202-e063-6394a90ae51c2026-08-20WarningsExact identifier
application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012
CVS Adult Cough plus Chest Congestion DM Max with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY822d5bf6-8841-4b7f-bbf7-90c3d50b80242026-08-19WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
application number: M012
Daytime and Nighttime Cough and Chest Congestion ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATECVS Pharmacy347f1731-5b85-4220-ae2b-9497a3afa4ed2026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACYe1c246a4-7a8c-4761-ab26-13b5165029cc2026-08-19WarningsExact identifier
application number: M012
CVS childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRCVS PHARMACY035c5e2a-04e3-490b-8f1a-233a5cb6eadb2026-08-19WarningsExact identifier
application number: M012
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories89752c69-25c8-45e3-9021-f81b35b52d362026-08-19WarningsExact 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