ALLERGY RELIEF

Product NDC: 0363-0100
11-digit product format: 003630100
Labeler code: 0363
Product ID: 0363-0100_385fdd93-c3a3-d252-e063-6394a90ab2ac
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: WALGREENS
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-12-31
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

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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-0100-61	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-0100-65	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-0100-61	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-0100-65	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0100-61	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0100-65	`0efc9e666f02…`	`f202fb6c5f17…`

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: 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
c0270298-e7c5-e500-e053-2995a90aed23	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, Related label table
NDC	Effective	Related label
0363-0100-61	2025-02-11	160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets
0363-0100-65	2025-02-11	160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets
0363-0100-61	2025-01-30	160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets
0363-0100-65	2025-01-30	160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-0100-61	ALLERGY RELIEF	600 in 1 BOTTLE	TABLET, FILM COATED	600		4
0363-0100-65	ALLERGY RELIEF	365 in 1 BOTTLE	TABLET, FILM COATED	365		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0100	ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [WALGREENS]	3	Current NDC, Legacy NDC, 2 package rows	20250213_c0270298-e7c5-e500-e053-2995a90aed23.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Original	OXYMETAZOLINE HYDROCHLORIDE	SAFEWAY, INC.	f7ad687b-dcaf-928c-e053-6294a90a6abe	2025-10-16	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	90ccb29c-9967-46cb-a409-e440344e1a1a	2025-10-15	Warnings	Exact identifier application number: M012
Robitussin Childrens Honey Day Night DM Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	f9999875-3433-4052-a628-39539d373216	2025-10-15	Warnings	Exact identifier application number: M012
Robitussin Day and Night Cough Relief Value Pack	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	Haleon US Holdings LLC	4029eccd-5443-4ae2-9232-2a1d922798f8	2025-10-15	Warnings	Exact identifier application number: M012
EndaCof DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	c68ea55a-8b9a-4a70-8b5c-1a2736651813	2025-10-15	Warnings	Exact identifier application number: M012
DURATUSS DM	DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	413a3951-d704-f14b-e063-6394a90a06dc	2025-10-15	Warnings	Exact identifier application number: M012
LoHist DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	29730dab-fa09-4351-9b36-0359ba4f7744	2025-10-15	Warnings	Exact identifier application number: M012
M-END DMX	DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	R. A. McNeil Company	ee1fae2e-3a21-4487-9989-c7620a4a7056	2025-10-15	Warnings	Exact identifier application number: M012
Chlo Tuss	CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	R.A. McNeil Company	43610aaa-8b94-40d5-ae09-3d75bd2317c8	2025-10-15	Warnings	Exact identifier application number: M012
Chlo Hist	CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE	R. A. McNeil Company	d046f4ba-5753-4ed5-a924-0b66fd116781	2025-10-15	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	6ca7372b-50c4-4b15-b133-fefa35525ade	2025-10-15	Warnings	Exact identifier application number: M012
Extra Strength Sinus Relief Nasal Decongestant	PHENYLEPHRINE HYDROCHLORIDE	CARDINAL HEALTH	0d8a009c-30b5-4f12-90bd-f8aa1110243f	2025-10-14	Warnings	Exact identifier application number: M012
Tussin DM Cough plus Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Cardinal Health 110, Inc. DBA LEADER	9d11f443-c93d-44e8-b5a3-2677b7b11212	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pecho SF	GUAIFENESIN	Efficient Laboratories, Inc.	31ff48fc-9603-413c-ab7c-2598b3e08f9c	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pecho DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	d108c712-bc36-41d7-9ccd-720496b5599e	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pechito DM for Kids	DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	004d12e1-6e3d-84c8-e063-6394a90aa653	2025-10-14	Warnings	Exact identifier application number: M012
VANACOF CP Allergy / Cough	CHLOPHEDIANOL HCL, PYRILAMINE MALEATE	GM Pharmaceuticals, INC	0bdea30a-39da-6611-e063-6394a90aa4cf	2025-10-14	Warnings	Exact identifier application number: M012
VANACOF	CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE	GM Pharmaceuticals, INC	cf3886ab-62b3-497a-a587-18cbfbaf3634	2025-10-14	Warnings	Exact identifier application number: M012
Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	42d4bafb-b630-487e-b63d-13ad37a59454	2025-10-14	Warnings	Exact identifier application number: M012
SUPRESS A	DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dextrum Laboratories, Inc	410c19f7-213d-cd99-e063-6294a90af5a3	2025-10-13	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	c0270298-e7c5-e500-e053-2995a90aed23	4
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	c0270298-e7c5-e500-e053-2995a90aed23	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0100-61	00363010061	600 TABLET, FILM COATED in 1 BOTTLE (0363-0100-61)	2021-12-31	0000-00-00	No	No	Current
0363-0100-65	00363010065	365 TABLET, FILM COATED in 1 BOTTLE (0363-0100-65)	2021-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
160R Walgreens 0363 0100 Diphenhydramine Hydrochloride 25 mg tablets	WALGREENS \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2025-06-25	HUMAN OTC DRUG LABEL	4