Sleep Aid

Product NDC: 55910-798
11-digit product format: 559100798
Labeler code: 55910
Product ID: 55910-798_6d10ff6d-37fd-4107-bb19-22496532cda7
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCL
Dosage form: CAPSULE
Route: ORAL
Labeler: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-18
Marketing end: 2028-07-28
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
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: Sleep Aid

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 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
1020477	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
651b03a3-b85e-4028-a9f2-472bec16c8f4	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55910-798-16	Sleep Aid	1 in 1 BLISTER PACK	CAPSULE	1		1
55910-798-16	Sleep Aid	16 in 1 CARTON	CAPSULE	16		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-798	SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]	1	Current NDC, 2 package rows	20240229_651b03a3-b85e-4028-a9f2-472bec16c8f4.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 145 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Consortium, LLC	8cb0d0c8-c565-4c5a-97c5-8250a67e23a8	2024-10-24	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	0d07a534-c67f-4041-a07c-ed7f68dfc426	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	90977b39-8ced-46bf-9d06-15306bce9b35	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb	2024-10-23	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e2325f33-e4e4-1269-e053-2995a90ab4ac	2024-10-23	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a8240d98-f0b0-3ded-e053-2a95a90a5cf9	2024-10-23	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a82401f5-65b1-11e9-e053-2a95a90a499e	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a823db21-4863-45a6-e053-2995a90ab8e6	2024-10-23	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e2346d0c-75cf-974c-e053-2a95a90a2857	2024-10-23	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Marc Glassman, Inc.	ce573785-f77d-4314-9b7a-ef3f1f4f34d8	2024-10-23	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e41a3dcc-45b4-4093-e053-2995a90a3b14	2024-10-23	Warnings	Exact identifier application number: M012
Cold plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e41a7cc5-bd0e-b92b-e053-2995a90af50a	2024-10-23	Warnings	Exact identifier application number: M012
Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Kroger Company	1cd26a6a-4b50-4610-9fc8-278545d77f18	2024-10-23	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	c5dd40e5-b4e2-4963-9a53-b71da1ed5510	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	832eb36c-21c6-46d7-b1f8-ab8b6f1e501e	2024-10-22	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	c9d82968-b2ec-2f4b-e053-2a95a90a7f0c	2024-10-22	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	b9d9ab99-44b1-455f-a29a-95c193a4808e	2024-10-22	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HARRIS TEETER	b96c376e-578f-1124-e053-2a95a90acbb4	2024-10-22	Warnings	Exact identifier application number: M012
Tukol Honey Daytime and Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	Genomma Lab USA	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	2024-10-22	Warnings	Exact identifier application number: M012
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	c92b508b-e5f9-4149-8c4b-d21845943b3b	2024-10-22	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
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	651b03a3-b85e-4028-a9f2-472bec16c8f4	1
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	651b03a3-b85e-4028-a9f2-472bec16c8f4	1
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	651b03a3-b85e-4028-a9f2-472bec16c8f4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-798-16	55910079816	16 BLISTER PACK in 1 CARTON (55910-798-16) / 1 CAPSULE in 1 BLISTER PACK	16 blister pack	2021-03-18	2028-07-28	No	No	Historical