Sleep Aid

Product NDC: 55319-367
11-digit product format: 553190367
Labeler code: 55319
Product ID: 55319-367_ca5419cb-5e17-48ed-97ab-7b48dab5482f
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Family Dollar Services Inc
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2000-06-10
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

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
Brand name suffix: Nighttime
Listing expiration: 2027-12-31

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
8ebd9949-ef53-4d66-a20c-3e0047b3e1ef	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	SPL version
55319-367-08	Sleep AidNighttime	2 in 1 CARTON	TABLET, FILM COATED	2	12
55319-367-08	Sleep AidNighttime	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	12
55319-367-12	Sleep AidNighttime	100 in 1 BOTTLE	TABLET, FILM COATED	100	12
55319-367-12	Sleep AidNighttime	1 in 1 CARTON	TABLET, FILM COATED	1	12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-367	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR SERVICES INC]	11	Current NDC, Legacy NDC, 4 package rows	20250519_8ebd9949-ef53-4d66-a20c-3e0047b3e1ef.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 3 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	2d63400b-43ae-4dd2-b917-3f65e02366b4	2026-06-08	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	TOPCO ASSOCIATES LLC	9558cc42-d27d-42af-b0a7-44cad025165d	2026-05-21	Warnings	Exact identifier application number: M010
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	dac2a0b9-f851-467b-a39f-3560d42c96e2	2026-05-20	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Walgreen Company	ec3618dd-8713-4f3c-b639-fc240021c7be	2026-05-13	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Rite Aid Corporation	fbedb50d-b96f-4ce4-a1dc-d2b357cf6de1	2026-05-13	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	8ebd9949-ef53-4d66-a20c-3e0047b3e1ef	2026-05-13	Warnings	Exact identifier application number: M010 ndc (product): 55319-367
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	CVS Pharmacy	0be4ef9a-2484-41dd-8bb8-e92d411f1384	2026-05-11	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	ca052b38-de38-7bf0-e053-2995a90a4e85	2026-05-11	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	e68d96c8-21c5-406c-b22c-3e384027c79f	2026-05-07	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Kroger Company	b71bb567-5605-430b-b3fa-048fe9bbe8ff	2026-05-04	Warnings	Exact identifier application number: M010
Sleep II Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Walgreen Company	ed864c84-a430-4ca8-87e8-04f1c1df538b	2026-05-04	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Walgreen Company	f8f17615-e4ec-49d4-9c0d-581d0fd6feb7	2026-04-28	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	888dc258-d5a3-4b62-aea1-c81ea29ff6f5	2026-04-28	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Amerisource Bergen	8f1cb631-4633-4ef5-868e-48a46ab311a4	2026-04-27	Warnings	Exact identifier application number: M010
VICKS ZzzQuil NIGHTTIME SLEEP-AID	DIPHENHYDRAMINE HCL	The Procter & Gamble Manufacturing Company	05f77c69-c8ea-f8ba-e063-6394a90aa60f	2026-04-23	Warnings	Exact identifier application number: M010
Vicks ZzzQuil Night Pain	DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	f3bb75e8-3d43-f91e-e053-2a95a90a584d	2026-04-23	Warnings	Exact identifier application number: M010
Nightime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	BETTER LIVING BRANDS LLC.	202bb1ff-3273-4872-e063-6294a90abebb	2026-04-11	Warnings	Exact identifier application number: M010
Vicks ZzzQuil Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	1be2f00b-5bdd-82e7-e063-6394a90ab9a5	2026-04-06	Warnings	Exact identifier application number: M010
Night Time Sleep Aid	DIPHENHYDRAMINE HCL	HyVee Inc	cf94fa56-01a5-4d6c-ad08-38b0ea363399	2026-04-03	Warnings	Exact identifier application number: M010
Sleep-Aid	DIPHENHYDRAMINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	84ec323d-0523-41e8-856c-e02d6afdc9ec	2026-04-02	Warnings	Exact identifier application number: M010

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	8ebd9949-ef53-4d66-a20c-3e0047b3e1ef	12
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	8ebd9949-ef53-4d66-a20c-3e0047b3e1ef	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-367-08	55319036708	2 BLISTER PACK in 1 CARTON (55319-367-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2000-06-10		No	No	Current
55319-367-12	55319036712	1 BOTTLE in 1 CARTON (55319-367-12) / 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2000-06-10	2026-11-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Family Wellness 44-367	Family Dollar Services Inc \| LNK International, Inc.	2026-05-13	HUMAN OTC DRUG LABEL	12