careone nighttime sleep aid

Product NDC: 41520-431
11-digit product format: 415200431
Labeler code: 41520
Product ID: 41520-431_3c6e54e3-91a1-4696-ab6f-3b049193ab8d
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Sales Company
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-04-13
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

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: careone nighttime sleep aid
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
14803f99-52c7-4324-b64c-971906144739	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
41520-431-62	2024-01-30	C162847	48780-1	1030e365-01bf-111a-e063-dadaa90a10e2	American Sales Company NIGHTTIME SLEEP AID Drug Facts
41520-431-67	2024-01-30	C162847	48780-1	1030e365-01bf-111a-e063-dadaa90a10e2	American Sales Company NIGHTTIME SLEEP AID Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41520-431-62	careone nighttime sleep aid	12 in 1 CARTON	TABLET, FILM COATED	12	5
41520-431-62	careone nighttime sleep aid	2 in 1 BLISTER PACK	TABLET, FILM COATED	2	5
41520-431-67	careone nighttime sleep aid	2 in 1 BLISTER PACK	TABLET, FILM COATED	2	5
41520-431-67	careone nighttime sleep aid	24 in 1 CARTON	TABLET, FILM COATED	24	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-431	CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN SALES COMPANY]	5	Current NDC, Legacy NDC, 4 package rows	20240724_14803f99-52c7-4324-b64c-971906144739.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 4 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sleep Aid	DIPHENHYDRAMINE HCL	Cardinal Health 110, LLC. DBA Leader	1d73e966-aa4a-40a0-b42a-fda8e500756e	2026-03-13	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Walgreens	ea1b5ec1-3c8e-437d-8e37-f38ab66d9f78	2026-03-13	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8dc17b5d-1cf7-44d2-9e78-d2c6952c7d20	2026-03-11	Warnings	Exact identifier application number: M010
sleep aid	DIPHENHYDRAMINE HCL	Rite Aid Corporation	bdfd7d87-2b54-4c29-ba69-aad0fab682e7	2026-03-11	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	5ef35ab9-b6e8-4c88-a623-35ac9d6bd359	2026-03-05	Warnings	Exact identifier application number: M010
Sleep-Aid	DIPHENHYDRAMINE HCL	WALMART INC. (see also Equate)	84c37f4d-60f6-490e-ba8b-47d1257fa6f8	2026-02-13	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	P & L Development, LLC	59c063ad-6ea3-4f1d-a20e-5e5e062a9098	2026-02-10	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	f446e56f-c664-4092-8712-aa3f204172f8	2026-02-02	Warnings	Exact identifier application number: M010
Sleep Aid Night Time	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	d805fab3-9dca-497f-bdc6-c8a7b1736109	2026-01-27	Warnings	Exact identifier application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	0e45d0e8-3741-7cee-e063-6394a90a2de5	2026-01-27	Warnings	Exact identifier application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	335b09c6-ee5d-ebdf-e063-6294a90abd12	2026-01-27	Warnings	Exact identifier application number: M010
Diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	32033991-a4f0-f767-e063-6394a90a0b06	2026-01-27	Warnings	Exact identifier application number: M010
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	90506598-046f-48d3-b8f5-d6ead0333812	2026-01-27	Warnings	Exact identifier application number: M010
DORMMY-LON	DIPHENHYDRAMINE HYDROCHLORIDE	Haendel Farma, S.A. de C.V.	562db961-83cb-4b74-9f34-fecee2c1be17	2026-01-27	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	dec955d3-817d-454f-b146-9a631e908dbc	2026-01-27	Warnings	Exact identifier application number: M010
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Prodose, Inc.	c4bc3efd-8ca8-22fe-e053-2a95a90aed45	2026-01-26	Warnings	Exact identifier application number: M010
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	f000d0b5-8ee8-4db0-99fe-aae5ed20c98e	2026-01-19	Warnings	Exact identifier application number: M010
Unisom SleepMinis Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Chattem, Inc.	a9a44c2f-65eb-4a5a-9e72-43652dce57f7	2026-01-14	Warnings	Exact identifier application number: M010
Unisom SleepMelts Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Chattem, Inc.	9105f4f1-7f94-408d-a025-83afb68dc9f0	2026-01-14	Warnings	Exact identifier application number: M010
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	462ca6cd-8eec-09df-e063-6294a90ac880	2026-01-13	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	14803f99-52c7-4324-b64c-971906144739	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	14803f99-52c7-4324-b64c-971906144739	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-431-62	41520043162	12 BLISTER PACK in 1 CARTON (41520-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK	12 blister pack	2004-04-13	0000-00-00	No	No	Current
41520-431-67	41520043167	24 BLISTER PACK in 1 CARTON (41520-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK	24 blister pack	2008-08-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company NIGHTTIME SLEEP AID Drug Facts	American Sales Company	2024-07-17	HUMAN OTC DRUG LABEL	5