allergy

Product NDC: 56062-479
11-digit product format: 560620479
Labeler code: 56062
Product ID: 56062-479_d0b0bff2-487d-4fe0-a933-3ca2c6d07596
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Publix Super Markets Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1998-05-07
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

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	56062-479	56062-479-62	D	Discontinued by firm		2026-10-23
excluded package	package	56062-479	56062-479-67	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 · 20 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	56062-479-62	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	56062-479-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	56062-479-62	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	56062-479-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	56062-479-62	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	56062-479-67	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	56062-479-62	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	56062-479-67	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	56062-479-62	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	56062-479-67	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	56062-479-62	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	56062-479-67	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	56062-479-62	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	56062-479-67	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	56062-479-62	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	56062-479-67	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	56062-479-62	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	56062-479-67	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	56062-479-67	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	56062-479-67	`367a005e9d99…`	`383a685ebd0f…`

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
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
23a98385-28cc-4fac-8c87-b3ced8106532	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
56062-479-62	2024-01-30	C162847	48780-1	1030e365-4f94-111a-e063-dadaa90a10e2	Publix Super Markets, Inc. Allergy Tablets Drug Facts
56062-479-67	2024-01-30	C162847	48780-1	1030e365-4f94-111a-e063-dadaa90a10e2	Publix Super Markets, Inc. Allergy Tablets Drug Facts
56062-479-78	2024-01-30	C162847	48780-1	1030e365-4f94-111a-e063-dadaa90a10e2	Publix Super Markets, Inc. Allergy Tablets Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
56062-479-62	allergy	24 in 1 CARTON	TABLET	24	7
56062-479-62	allergy	1 in 1 BLISTER PACK	TABLET	1	7
56062-479-67	allergy	1 in 1 BLISTER PACK	TABLET	1	7
56062-479-67	allergy	48 in 1 CARTON	TABLET	48	7
56062-479-78	allergy	100 in 1 BOTTLE	TABLET	100	7
56062-479-78	allergy	1 in 1 CARTON	TABLET	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
56062-479-62	EA - Each	56062-479	d2cf61c4-ba45-4d60-9400-745f0775349b	1	2013-09-04
56062-479-67	EA - Each	56062-479	442a691a-7f8c-41a7-9d18-739a879f46ed	1	2013-09-04
56062-479-78	EA - Each	56062-479	5d6e0869-6e01-4fd8-8d13-9b794e22969d	1	2013-09-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
56062-479	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]	7	Current NDC, Legacy NDC, 6 package rows	20240722_23a98385-28cc-4fac-8c87-b3ced8106532.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 101 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Dextrum Laboratories, Inc	3f79137f-f0b0-d22c-e063-6394a90a7245	2025-09-23	Warnings	Exact identifier application number: M012
GoodSense Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	GOOD SENSE	240bb6af-9d38-49fe-9011-3016246b0986	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Honey Lemon Cough Drops	HONEY LEMON COUGH DROPS	Cintas Corporation	79e0b7c1-4acc-41d2-89cd-d075a8bac0c9	2025-09-23	Warnings	Exact identifier application number: M012
Topcare NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	b2b3c450-e988-41d1-9e53-cc8e30d75cb4	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Cherry Cough Drops	CHERRY COUGH DROPS	Cintas Corporation	d1fd2f23-5435-405d-a7fd-644691f79e80	2025-09-23	Warnings	Exact identifier application number: M012
Topcare DayTime NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	560fb22b-391f-4d7b-a6fd-38d577d404b0	2025-09-23	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Dextrum Laboratories Inc.	3f67ac3d-1503-3418-e063-6394a90a938f	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories Inc.	3f68e68a-cf32-9df8-e063-6394a90a3012	2025-09-22	Warnings	Exact identifier application number: M012
SUPRESS A	DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kramer Novis	f0bec5f5-4d76-471e-9024-557eba848b93	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	9f050fb0-6100-4b14-b82f-1d5fcbf16540	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	c6392ace-c7d1-4450-8b71-4dccc60b4f02	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f12ee8f-d1c6-d73a-e063-6394a90a9199	2025-09-18	Warnings	Exact identifier application number: M012
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3d71d306-893a-e73a-e063-6394a90a0a3b	2025-09-18	Warnings	Exact identifier application number: M012
Giltuss D	GILTUSS D	Dextrum Laboratories Inc.	3f17eefb-b625-b0f2-e063-6294a90afd4d	2025-09-18	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Major Pharmaceuticals	6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b	2025-09-17	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Dextrum Laboratories Inc	3effaf4b-28c3-6131-e063-6294a90a17ff	2025-09-17	Warnings	Exact identifier application number: M012
AXIV DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	1872e1ff-2e08-c404-e063-6294a90afa14	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1323a67c-b9c5-038c-e063-6394a90a5e6b	2025-09-17	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f025ef6-79e7-e833-e063-6294a90ab501	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	186f8519-655d-bd21-e063-6294a90a16a8	2025-09-17	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	23a98385-28cc-4fac-8c87-b3ced8106532	7
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	23a98385-28cc-4fac-8c87-b3ced8106532	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
56062-479-62	56062047962	24 BLISTER PACK in 1 CARTON (56062-479-62) > 1 TABLET in 1 BLISTER PACK	24 blister pack	1998-05-07	0000-00-00	No	No	Current
56062-479-67	56062047967	48 BLISTER PACK in 1 CARTON (56062-479-67) > 1 TABLET in 1 BLISTER PACK	48 blister pack	2002-04-18	0000-00-00	No	No	Current
56062-479-78	56062047978	1 BOTTLE in 1 CARTON (56062-479-78) / 100 TABLET in 1 BOTTLE	1 bottle	2007-11-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Publix Super Markets, Inc. Allergy Tablets Drug Facts	Publix Super Markets Inc	2024-07-16	HUMAN OTC DRUG LABEL	7