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 15 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense allergy	DIPHENHYDRAMINE HCL	L. Perrigo Company	bf5039a0-2109-41a2-84a9-b5167d0a93da	2026-07-22	Warnings	Exact identifier application number: M012
Congestion and Headache	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	432c3ec4-7595-4213-94e3-ce41af91804e	2026-07-21	Warnings	Exact identifier application number: M012
SKAPEMED ORIGINAL NASAL	NAPHAZOLINE HCL 0.05% ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a208a1f-f6e8-0b4a-e063-6294a90a10c8	2026-07-21	Warnings	Exact identifier application number: M012
SERYNTH FAST RELIEF NASAL	NAPHAZOLINE HCL 0.05% FAST RELIEF NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4abdc0-aded-1b8a-e063-6394a90a9b56	2026-07-21	Warnings	Exact identifier application number: M012
DERMFREE ORIGINAL NASAL	NAPHAZOLINE HCL0.05%ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d0c03-7d8f-76cb-e063-6394a90a938c	2026-07-21	Warnings	Exact identifier application number: M012
DERMFREE ORIGINAL NASAL	NAPHAZOLINE HCL 0.05%ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d3a2b-a4ed-c736-e063-6394a90a96df	2026-07-21	Warnings	Exact identifier application number: M012
Severe Cough and Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	791eaac1-ddb5-40e2-9040-52dfadc30e06	2026-07-21	Warnings	Exact identifier application number: M012
DRx Choice DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Raritan Pharmaceuticals Inc.	9ab47b10-b1ed-4ae1-94e8-09d50e952bb0	2026-07-21	Warnings	Exact identifier application number: M012
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	P & L Development, LLC	17639c3b-5d36-41f5-bd0d-da29075abd09	2026-07-21	Warnings	Exact identifier application number: M012
NATUHEAL ORIGINAL NASAL	NAPHAZOLINE HCL 0.05% ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a470b9e-c83f-fb20-e063-6294a90a2f13	2026-07-20	Warnings	Exact identifier application number: M012
TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	1c444202-19e9-8d04-e063-6394a90a9294	2026-07-20	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS HONEY LEMON	DISCOUNT DRUG MART	5565a581-e2b5-81a5-e063-6394a90af409	2026-07-20	Warnings	Exact identifier application number: M012
Best Choice Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	40e0b17a-5704-4203-8f0a-11b2fcf81f8f	2026-07-17	Warnings	Exact identifier application number: M012
Equate Daytime Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALMART INC.	ee1ef41d-b8be-42f3-9918-ccf1c0a80241	2026-07-17	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	879a7804-f3d4-4a3d-bc92-b473499d6c95	2026-07-17	Warnings	Exact identifier application number: M012
Best Choice	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	95007785-ddf6-4386-af5f-84dac1066b40	2026-07-17	Warnings	Exact identifier application number: M012
BEST CHOICE No Drip	ALLERGY SINUS	BEST CHOICE (VALU MERCHANDISERS COMPANY)	d5f95b56-8201-4d97-82ab-e23761bfe720	2026-07-17	Warnings	Exact identifier application number: M012
Best Choice Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	7d19fdba-35b0-424a-ba11-315521d3256d	2026-07-17	Warnings	Exact identifier application number: M012
Best Choice Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	badb15ac-91e8-4962-96f5-beb250977560	2026-07-17	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0839c07b-f692-4af1-85b8-da60fb281d49	2026-07-17	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	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