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
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b52fc311-8853-4116-941b-8be35456abba	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68391-200-79	2024-01-30	C162847	48780-1	1030e365-44da-111a-e063-dadaa90a10e2	BJWC Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68391-200-79	Berkley and Jensen Allergy Relief	400 in 1 BOTTLE	TABLET	400		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68391-200	BERKLEY AND JENSEN ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [BJWC]	6	Current NDC, Legacy NDC, 1 package rows	20240720_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 116 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pharmacys Prescription Vapor Rub	MENTHOL	American Consumer Products Corp	31aa54d8-df8d-f1ae-e063-6294a90a9622	2025-03-31	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Bryant Ranch Prepack	570a71eb-2d19-4c7b-8c00-e1524bfa3844	2025-03-31	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	KESIN PHARMA CORPORATION	365c01b7-a197-4876-85fc-42204f787e3a	2025-03-28	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	59aeb692-2f79-45aa-8e6a-dab77cd3b2f9	2025-03-28	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Oncor Pharmaceuticals	06ecba97-c790-4672-a8c3-f9caf6272d26	2025-03-27	Warnings	Exact identifier application number: M012
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	87ebb4d9-78d7-1c87-e053-2a95a90adb7d	2025-03-27	Warnings	Exact identifier application number: M012
REVASOL CHILDRENS ALLERGY	DIPHENHYDRAMINE HCL	Rnv LLC	3143137f-ef42-5358-e063-6394a90a8ed1	2025-03-26	Warnings	Exact identifier application number: M012
Rompe Pecho SF FLU	DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Efficient Laboratories Inc	bc10695a-9664-4ce3-82bb-820da06129fa	2025-03-26	Warnings	Exact identifier application number: M012
SUPRESS-PE Pediatric	GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	a474171d-5c29-4a80-9d37-00613796211a	2025-03-26	Warnings	Exact identifier application number: M012
Guaifenesin DM	DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN	Innovida Pharmaeutique Corporation	dd3f806b-2470-4055-94e1-18adac811025	2025-03-25	Warnings	Exact identifier application number: M012
Foster and Thrive childrens cold cough relief dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	38b710e3-1d01-4ff4-a6b6-44936f277f49	2025-03-25	Warnings	Exact identifier application number: M012
Revasol Tussin DM Max with Honey	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Rnv LLC	30da9255-c93a-84d6-e063-6394a90a7c2a	2025-03-21	Warnings	Exact identifier application number: M012
REVASOL NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Rnv LLC	30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9	2025-03-21	Warnings	Exact identifier application number: M012
Chest Congestion Relief	GUAIFENESIN	Meijer, Inc.	261a79b3-5704-76f2-e063-6394a90a5ac6	2025-03-20	Warnings	Exact identifier application number: M012
Rompe Tos X Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cc932d-b412-0710-e063-6394a90a87f6	2025-03-19	Warnings	Exact identifier application number: M012
Rompe Tos X Adults	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05abb2db-d22e-90b5-e063-6294a90ace3f	2025-03-19	Warnings	Exact identifier application number: M012
Sinus Head Congestion	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	30a07773-bd6f-b9f2-e063-6394a90ab8aa	2025-03-18	Warnings	Exact identifier application number: M012
Halls Sugar Free Black Cherry	MENTHOL	Mondelez Global LLC	bd2a311a-bf0c-4365-af9b-76675c243b22	2025-03-16	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	TARGET CORPORATION	fbca9627-5e12-048a-e053-6294a90a6e0f	2025-03-15	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	DOLGENCORP, INC.	0655688e-7c42-507f-e063-6294a90ae498	2025-03-15	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	b52fc311-8853-4116-941b-8be35456abba	6
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	b52fc311-8853-4116-941b-8be35456abba	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68391-200-79	68391020079	400 TABLET in 1 BOTTLE (68391-200-79)	400 tablet	2013-12-10	0000-00-00	No	No	Current