Nighttime Sleep Aid

Product NDC: 41520-034
Requested package NDC: 41520-034-06
11-digit product format: 415200034
Labeler code: 41520
Product ID: 41520-034_dc496e69-0bf8-4215-ac37-4f7256115d90
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Care One (American Sales Company)
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-06-30
Marketing end: 2026-10-30
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/30mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
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: Nighttime Sleep Aid

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
bd5de3b3-7cb5-4403-b664-23ac70b9957f	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	Strength	SPL version
41520-034-06	Nighttime Sleep Aid	177 mL in 1 BOTTLE, PLASTIC	LIQUID	177		7
41520-034-12	Nighttime Sleep Aid	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-034	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)]	6	Current NDC, Legacy NDC, 2 package rows	20240306_bd5de3b3-7cb5-4403-b664-23ac70b9957f.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 153 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
COLD AND FLU NIGHTTIME SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9c34e-a0ca-cdf9-e053-2a95a90a93d3	2024-09-25	Warnings	Exact identifier application number: M012
Basic Care Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	8f3317f6-4ae8-474b-93c3-25e256519cb8	2024-09-25	Warnings	Exact identifier application number: M012
berkley and jensen tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	BJWC	b2de91c9-6af0-4881-8d2d-a69d90c8dfcd	2024-09-24	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Non Drowsy	DEXTROMETHORPHAN HBR, GUAIFENESIN	WinCo Foods, LLC	13eb459c-3075-4038-8062-9ee7175b2ab9	2024-09-24	Warnings	Exact identifier application number: M012
equaline nasal decongestant non drowsy maximum strength	PSEUDOEPHEDRINE HCL	United Natural Foods, Inc. dba UNFI	8897580a-709a-4643-8264-ad003d90cbff	2024-09-22	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	bd5de3b3-7cb5-4403-b664-23ac70b9957f	7
1248354	diphenhydramine hydrochloride 1.67 MG/ML Oral Solution	SCD	bd5de3b3-7cb5-4403-b664-23ac70b9957f	7
1248354	diphenhydramine HCl 1.667 MG/ML Oral Solution	SY	bd5de3b3-7cb5-4403-b664-23ac70b9957f	7
1248354	diphenhydramine HCl 50 MG per 30 ML Oral Solution	SY	bd5de3b3-7cb5-4403-b664-23ac70b9957f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-034-06	41520003406	177 mL in 1 BOTTLE, PLASTIC (41520-034-06)	177 ml	2015-06-30	2026-10-30	No	No	Current