Allergy Relief

Product NDC: 59779-923
11-digit product format: 597790923
Labeler code: 59779
Product ID: 59779-923_7ccc6bce-bda7-4bc0-8768-14e310bd122d
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CVS Pharmacy
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59779-923	59779-923-06	D	Discontinued by firm		2026-10-23
excluded package	package	59779-923	59779-923-07	D	Discontinued by firm		2026-10-23

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 · 14 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	59779-923-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59779-923-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	59779-923-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59779-923-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	59779-923-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	59779-923-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	59779-923-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	59779-923-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	59779-923-07	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	59779-923-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	59779-923-07	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	59779-923-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	59779-923-07	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	59779-923-07	`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
59779-923-03	Allergy Relief	10 in 1 BOTTLE	TABLET, FILM COATED	10	21
59779-923-03	Allergy Relief	1 in 1 PACKAGE	TABLET, FILM COATED	1	21
59779-923-06	Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1	21
59779-923-06	Allergy Relief	200 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	200	21
59779-923-07	Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1	21
59779-923-07	Allergy Relief	36 in 1 BLISTER PACK	TABLET, FILM COATED	36	21
59779-923-08	Allergy Relief	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	21
59779-923-08	Allergy Relief	2 in 1 CARTON	TABLET, FILM COATED	2	21
59779-923-12	Allergy Relief	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	21
59779-923-12	Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1	21
59779-923-22	Allergy Relief	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	21
59779-923-22	Allergy Relief	4 in 1 CARTON	TABLET, FILM COATED	4	21
59779-923-51	Allergy Relief	365 in 1 BOTTLE	TABLET, FILM COATED	365	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-923-06	EA - Each	59779-923	30110bad-301f-4dad-805c-dfa36e7445b9	1	2018-06-11
59779-923-08	EA - Each	59779-923	168d7f4c-0736-4b11-aa63-0fcbfcf2c6db	1	2019-07-02
59779-923-12	EA - Each	59779-923	72268e8a-847e-45bc-88b4-ed051ce515c3	1	2017-12-14
59779-923-22	EA - Each	59779-923	9e7cf901-db0a-4cba-aea8-17393dd51c7f	1	2019-07-02
59779-923-51	EA - Each	59779-923	ba2d6332-2a3c-4a5c-b542-aeaea5afed88	1	2017-11-06

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 [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-923	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [CVS PHARMACY]	20	Current NDC, Legacy NDC, 13 package rows	20250105_22f55699-4922-4c05-bdf5-5844c7dd3ee5.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 141 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra Strength TYLENOL Severe Cough Plus Sore Throat Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.	Kenvue Brands LLC	f81d924e-10e9-0e9d-e053-6294a90a2ddf	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	8b516736-86ac-47cb-a0ec-038d4c3a0020	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu plus Cough Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e85e5eb9-3ecf-4784-999e-111e38e306f5	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ef8a846d-4b29-4fd8-a683-fada04d0a2b9	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	9761c807-75a1-4498-a8c6-1f2b1c9ffde6	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Mucus Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	24ac94e8-b223-424e-bcd2-9c027c8ff9ed	2024-11-07	Warnings	Exact identifier application number: M012
Primatene	EPHEDRINE HYDROCHLORIDE	Foundation Consumer Brands	2170f081-c03f-47e8-bc63-4052c5e653fa	2024-11-07	Warnings	Exact identifier application number: M012
Rompe Pecho Max Multi Symptoms	ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN	EFFICIENT LABORATORIES INC	938e4e47-d2d9-4b0d-bf88-e9f41b501945	2024-11-07	Warnings	Exact identifier application number: M012
topcare sinus nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	ca1fefed-e9d7-430a-9da4-972b1a6fb786	2024-11-07	Warnings	Exact identifier application number: M012
Leader Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	dd82a389-9ec5-4b3f-a9ea-1a56871ebd17	2024-11-07	Warnings	Exact identifier application number: M012
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	1a8e2e03-e11b-4da1-945b-e2caadea7243	2024-11-07	Warnings	Exact identifier application number: M012
SUDOGEST NASAL DECONGESTANT	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	09feb5f0-c22d-4a1b-97a0-d5767e5f7730	2024-11-07	Warnings	Exact identifier application number: M012
up and up childrens allergy melts	DIPHENHYDRAMINE HCL	Target Corporation	f98d1d54-8e11-4bb1-825a-ab5447d37847	2024-11-07	Warnings	Exact identifier application number: M012
good sense severe day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	44130a1b-63cc-42ac-9590-fdf21a12d164	2024-11-07	Warnings	Exact identifier application number: M012
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	a5ff1134-8985-4585-8e61-a5fd5f60afeb	2024-11-07	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	50528d29-ce8c-4efb-a86c-17246b017db0	2024-11-07	Warnings	Exact identifier application number: M012
cooling severe daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	d4a21760-b2bd-4e26-bff0-6fc1b05d26b3	2024-11-07	Warnings	Exact identifier application number: M012
dg health day time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	60870311-3234-44ba-95dd-09cf4ea3d508	2024-11-07	Warnings	Exact identifier application number: M012
adult dm max cough and chest congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution Inc	3a6855c1-da6d-4fa9-81fe-d2e61355989f	2024-11-06	Warnings	Exact identifier application number: M012
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	e51dfb62-40d0-4bec-9574-90057cb35bcc	2024-11-06	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	22f55699-4922-4c05-bdf5-5844c7dd3ee5	21
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	22f55699-4922-4c05-bdf5-5844c7dd3ee5	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-923-03	59779092303	1 BOTTLE in 1 PACKAGE (59779-923-03) / 10 TABLET, FILM COATED in 1 BOTTLE	1 bottle	1990-03-02	0000-00-00	No	No	Current
59779-923-06	59779092306	1 BOTTLE, PLASTIC in 1 CARTON (59779-923-06) > 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		1990-03-02	0000-00-00	No	No	Current
59779-923-07	59779092307	1 in 1 CARTON						Historical
59779-923-08	59779092308	2 BLISTER PACK in 1 CARTON (59779-923-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	1990-03-02	0000-00-00	No	No	Current
59779-923-12	59779092312	1 BOTTLE, PLASTIC in 1 CARTON (59779-923-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		1990-03-02	0000-00-00	No	No	Current
59779-923-22	59779092322	4 BLISTER PACK in 1 CARTON (59779-923-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK	4 blister pack	1990-03-02	0000-00-00	No	No	Current
59779-923-51	59779092351	365 TABLET, FILM COATED in 1 BOTTLE (59779-923-51)		1990-03-02	0000-00-00	No	No	Current