Allergy Relief

Product NDC: 41163-329
11-digit product format: 411630329
Labeler code: 41163
Product ID: 41163-329_2e46a9aa-ff1b-4fda-aa1b-33aac03803c7
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: United Natural Foods, Inc. dba UNFI
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41163-329	41163-329-12	D	Discontinued by firm		2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41163-329-08	Allergy Relief	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	18
41163-329-08	Allergy Relief	2 in 1 CARTON	TABLET, FILM COATED	2	18
41163-329-12	Allergy Relief	100 in 1 BOTTLE	TABLET, FILM COATED	100	18
41163-329-12	Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1	18
41163-329-22	Allergy Relief	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	18
41163-329-22	Allergy Relief	4 in 1 CARTON	TABLET, FILM COATED	4	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-329-08	EA - Each	41163-329	b55a5746-95a7-4b09-b675-0735a3c8a23c	1	2023-05-05
41163-329-12	EA - Each	41163-329	ecd24238-f405-4f3e-ac66-184f573fb7bd	1	2016-06-14
41163-329-22	EA - Each	41163-329	de5d2551-c8ae-4274-aff6-af86e35d083f	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-329	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]	17	Current NDC, Legacy NDC, 6 package rows	20241023_4517c7ef-156c-42b8-a2da-165e936f0837.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 77 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	f6401b58-8cf8-4067-e053-2995a90a68fc	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1ba37b8-4558-0808-e053-2995a90a9f5e	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b84f37bc-be37-4f2b-83ee-d7d134184490	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1b7c7fc-1068-f486-e053-2a95a90a8e8c	2025-12-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	b1b9e0da-2c54-8b31-e053-2995a90a690b	2025-12-11	Warnings	Exact identifier application number: M012
Sinus Relief Daytime, Nighttime, Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	f6b3ca40-7638-477f-b800-4c28c40ff0a8	2025-12-11	Warnings	Exact identifier application number: M012
Allergy Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreen Company	0a6e3251-02e0-42c1-bdf3-51c77f88c17f	2025-12-11	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	516ab016-31f9-4829-8b94-2f968933093c	2025-12-11	Warnings	Exact identifier application number: M012
Sinus PE Congestion	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreen Company	5b9151b7-3e40-4f37-b3e0-4c0fa0115b71	2025-12-10	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Discount Drug Mart	2344c048-0550-4c31-b54e-a198910c490e	2025-12-10	Warnings	Exact identifier application number: M012
CVS Maximum Strength Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL	CVS PHARMACY, INC	cf4eb4c4-68e0-4478-a81c-d3d1e66f5cc5	2025-12-10	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu Severe, Lil Drug Store	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Lil Drug Store Products, Inc	f395c196-62d7-47ff-b38d-af37adf5980b	2025-12-10	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe, Lil Drug Store	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Lil Drug Store Products, Inc	88b68447-b016-4d5b-a5e3-c4ebccb14f8c	2025-12-10	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	d956f1b8-91f8-424b-bb6c-704c445b6f4c	2025-12-10	Warnings	Exact identifier application number: M012
good neighbor pharmacy day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	e5c1bd96-d27d-49c1-b3b8-eee53a145ef5	2025-12-10	Warnings	Exact identifier application number: M012
NiteTime SEVERE Cold and Flu Relief SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	3ffe67bf-2c66-61e6-e063-6394a90a7f8f	2025-12-10	Warnings	Exact identifier application number: M012
DayTime SEVERE Cold and Flu Relief SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	3ffe0f43-b92a-f947-e063-6394a90ab72c	2025-12-10	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	a7285fe0-5a5b-42c4-be47-9a07a2ba75e8	2025-12-10	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Rite Aid Corporation	f9b8dbe1-7ff9-4320-850c-6e86e98d4393	2025-12-09	Warnings	Exact identifier application number: M012
Severe Nasal	OXYMETAZOLINE HYDROCHLORIDE 0.05%	ALAINA HEALTHCARE PRIVATE LIMITED	27747a10-8d1d-41c2-80b9-45452f3b9abc	2025-12-09	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	4517c7ef-156c-42b8-a2da-165e936f0837	18
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	4517c7ef-156c-42b8-a2da-165e936f0837	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-329-08	41163032908	2 BLISTER PACK in 1 CARTON (41163-329-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	1990-03-02	0000-00-00	No	No	Current
41163-329-12	41163032912	100 in 1 BOTTLE						Historical
41163-329-22	41163032922	4 BLISTER PACK in 1 CARTON (41163-329-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK	4 blister pack	1990-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Equaline 44-329	United Natural Foods, Inc. dba UNFI \| LNK International, Inc.	2026-10-19	HUMAN OTC DRUG LABEL	19