Sleep Tabs

Product NDC: 69168-247
11-digit product format: 691680247
Labeler code: 69168
Product ID: 69168-247_51f0777e-6c05-48ee-bb31-a53f18c04627
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl Tablets
Dosage form: TABLET
Route: ORAL
Labeler: Allegiant Health
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-04-28
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: Sleep Tabs
Brand name suffix: For Nighttime use
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
566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	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
69168-247-24	2020-03-13	C162847	48780-1	9d75b9d0-48c4-f424-e053-dadaa90a57ce	Drug Facts
69168-247-24	2020-01-31	C162847	48780-1	9d75b9d0-48c4-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69168-247-24	Sleep TabsFor Nighttime use	24 in 1 BOTTLE, UNIT-DOSE	TABLET	24		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-247	SLEEP TABS FOR NIGHTTIME USE (DIPHENHYDRAMINE HCL TABLETS) TABLET [ALLEGIANT HEALTH]	5	Current NDC, Legacy NDC, 1 package rows	20231114_566e40b1-e9d7-44e4-b971-eef2b7cf0a7d.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 127 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Afrin Original	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	8a97c012-6a47-4607-9389-58a4eed17b08	2024-12-18	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Orazen Inc	ecddaa3b-e18f-1c74-e053-2995a90ad86a	2024-12-18	Warnings	Exact identifier application number: M012
Rite Aid Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Rite Aid	dfedbef1-8062-432d-e053-2a95a90a09e9	2024-12-18	Warnings	Exact identifier application number: M012
TheraCare Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Veridian Healthcare	f7801843-f96c-710e-e053-6294a90a5086	2024-12-18	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief G450	GUAIFENESIN	Rugby Laboratories	a6aa8cbd-21ff-4f84-b338-c05c2d46e6df	2024-12-18	Warnings	Exact identifier application number: M012
Refenesen Mucus Relief	GUAIFENESIN	Reese Pharmaceutical Co	861dffb7-8bf4-4f03-bcc2-ed8a35bc341d	2024-12-18	Warnings	Exact identifier application number: M012
Marcs Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Marc Glassman Inc	be3ad54f-522c-440d-b8c7-9664f6015566	2024-12-18	Warnings	Exact identifier application number: M012
Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee	2024-12-18	Warnings	Exact identifier application number: M012
Family Wellness Chest Congestion Relief	GUAIFENESIN	Family Dollar Services Inc	412f3459-4c22-4822-86bd-011fc3e91ca6	2024-12-18	Warnings	Exact identifier application number: M012
Marcs Mucus Relief	GUAIFENESIN	Marc Glassman Inc	455b9f01-206c-4534-a006-292d2bd48f47	2024-12-18	Warnings	Exact identifier application number: M012
Leader Chest Congestion Relief G450	GUAIFENESIN	Cardinal Health	4586a83f-077c-4fb3-adfe-7a9497a78d97	2024-12-18	Warnings	Exact identifier application number: M012
Foster and Thrive Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Strategic Sourcing Services LLC	5372f764-985e-4a42-bc97-cb0dc90fcd9c	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Chest Congestion and Cough Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	TOPCO ASSOCIATES LLC	5a2d0464-038d-4c3f-b39e-ee9984fb383e	2024-12-18	Warnings	Exact identifier application number: M012
Always Save Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Valu Merch	a72b6a97-f97f-44bb-8d55-ac48b8ba45c5	2024-12-18	Warnings	Exact identifier application number: M012
Harris Teeter Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	4ebe1d94-bb15-4250-a4c2-8cd45743c7dd	2024-12-18	Warnings	Exact identifier application number: M012
Care One Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	RETAIL BUSINESS SERVICES , LLC	f6657dee-9f32-45b1-8e44-1ad67a4a68bd	2024-12-18	Warnings	Exact identifier application number: M012
Childrens Metapp Daytime	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Guardian Drug Company	40565500-944b-47f2-8563-5df05469e418	2024-12-18	Warnings	Exact identifier application number: M012
CVS Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	CVS Pharmacy, Inc.	884abed2-e355-4134-92f1-591f3a18f71d	2024-12-18	Warnings	Exact identifier application number: M012
CVS Health Chest Congestion Relief PE	GUAIFENESIN/PHENYLEPHRINE	CVS Pharmacy, Inc.	a49020e8-739e-47ec-8141-e866479a3ab3	2024-12-18	Warnings	Exact identifier application number: M012
Family Wellness Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Family Dollar Services Inc	8aee8108-a4e0-4956-8e37-6b3b1c5dc683	2024-12-18	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	566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-247-24	69168024724	24 TABLET in 1 BOTTLE, UNIT-DOSE (69168-247-24)	24 tablet	2015-04-28	0000-00-00	No	No	Current