Sleep Aid

Product NDC: 55910-981
11-digit product format: 559100981
Labeler code: 55910
Product ID: 55910-981_dcba89a4-11b0-431e-88b3-7aba217b2637
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCL
Dosage form: LIQUID
Route: ORAL
Labeler: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-02-04
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/30mL
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	50 mg/30mL

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
1248354	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
4fff664b-4ff0-4007-95ab-cb273807b9b4	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
55910-981-02	Sleep AidNightTime	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355	5
55910-981-04	Sleep AidNightTime	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355	5
55910-981-04	Sleep AidNightTime	2 in 1 PACKAGE	LIQUID	2	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-981	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]	4	Current NDC, Legacy NDC, 3 package rows	20240731_4fff664b-4ff0-4007-95ab-cb273807b9b4.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 152 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough Drops	MENTHOL	Topco Associates LLC	eff16ba3-7e30-aa93-e053-2995a90a64cb	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	ebf6bcf5-9384-052a-e053-2a95a90a30a5	2024-10-07	Warnings	Exact identifier application number: M012
Rompe Pecho SF Flu SF Flu	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Efficient Laboratories Inc	06eac696-e8f6-ac50-e063-6394a90a2ed6	2024-10-07	Warnings	Exact identifier application number: M012
dg health nasal four	PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	ceeeb016-8e46-40b8-9923-8a4270475f45	2024-10-04	Warnings	Exact identifier application number: M012
Topcare Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	99bc8829-167b-4cf8-8421-57da369f24cd	2024-10-04	Warnings	Exact identifier application number: M012
basic care nasal	PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	858648f6-f454-4008-9ea8-ad060c217833	2024-10-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Navajo Manufacturing Company Inc.	f6068011-ad56-59b4-e053-2995a90ac016	2024-10-03	Warnings	Exact identifier application number: M012
Benadryl Ultratabs	DIPHENHYDRAMINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76433e3c-142c-4704-8b2b-d602f008c377	2024-10-02	Warnings	Exact identifier application number: M012
Afrin	OXYMETAZOLINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	65bf1556-f234-9439-e053-2a91aa0a3194	2024-10-02	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Proficient Rx LP	4eab4344-d95e-4b19-a21e-9c8ad033863a	2024-10-01	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Proficient Rx LP	a910320b-0585-40bd-928c-0406346281d0	2024-10-01	Warnings	Exact identifier application number: M012
CareOne Nasal and Sinus Decongestant	PSEUDOEPHEDRINE HCL	American Sales Company	81b31070-9b03-4ce4-8aac-a334544842ae	2024-10-01	Warnings	Exact identifier application number: M012
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	Proficient Rx LP	20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d	2024-10-01	Warnings	Exact identifier application number: M012
meijer Nighttime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	1bec5167-5fc5-2405-e063-6294a90a5358	2024-09-30	Warnings	Exact identifier application number: M012
good sense tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	A-S Medication Solutions	19b3db33-86d1-48f3-9525-c7c87a4b6899	2024-09-29	Warnings	Exact identifier application number: M012
nasal decongestant maximum strength non drowsy	PSEUDOEPHEDRINE HCL	Meijer Distribution Inc	8a68ca99-fd76-409a-9769-88830e8720a8	2024-09-28	Warnings	Exact identifier application number: M012
good neighbor pharmacy tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	58687394-b6d2-4d51-bde0-8f2cfa3fe909	2024-09-27	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Amerisource Bergen	faee3aae-e819-4084-a127-3449be353b13	2024-09-27	Warnings	Exact identifier application number: M012
Tesalon Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL	OPMX LLC	2309620a-ccbc-41e9-e063-6394a90a9520	2024-09-26	Warnings	Exact identifier application number: M012
adult cough and chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Meijer, Inc.	b11c4cee-bbb5-4585-9d38-6787553e13a0	2024-09-26	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
1248354	diphenhydrAMINE HCl 50 MG in 30 mL Oral Solution	PSN	4fff664b-4ff0-4007-95ab-cb273807b9b4	5
1248354	diphenhydramine hydrochloride 1.67 MG/ML Oral Solution	SCD	4fff664b-4ff0-4007-95ab-cb273807b9b4	5
1248354	diphenhydramine HCl 1.667 MG/ML Oral Solution	SY	4fff664b-4ff0-4007-95ab-cb273807b9b4	5
1248354	diphenhydramine HCl 50 MG per 30 ML Oral Solution	SY	4fff664b-4ff0-4007-95ab-cb273807b9b4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-981-02	55910098102	355 mL in 1 BOTTLE, PLASTIC (55910-981-02)	355 ml	2022-02-04	0000-00-00	No	No	Current
55910-981-04	55910098104	2 BOTTLE, PLASTIC in 1 PACKAGE (55910-981-04) / 355 mL in 1 BOTTLE, PLASTIC		2022-02-04	0000-00-00	No	No	Current