Nite-Time

Product NDC: 57243-501
11-digit product format: 572430501
Labeler code: 57243
Product ID: 57243-501_99da41d1-ae1e-4a3a-b51a-11bed23be8bf
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form: LIQUID
Route: ORAL
Labeler: Salado Sales, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-01-16
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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: Nite-Time
Brand name suffix: COLD/FLU ORIGINAL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/30mL
DOXYLAMINE SUCCINATE	12.5 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043400	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
fcd24753-b42b-4d05-8379-0ec0351ab217	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57243-501-25	Nite-TimeCOLD/FLU ORIGINAL	177 mL in 1 BOTTLE	LIQUID	177		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57243-501	NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20231230_fcd24753-b42b-4d05-8379-0ec0351ab217.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFANTS PAIN AND FEVER	ACETAMINOPHEN	Amazon.com Services LLC	112076c4-cac2-45ab-9c77-5573edae7180	2026-07-10	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Wal-Mart Stores Inc	8ae16aa2-54bc-4c1a-aa36-93524199a67b	2026-07-09	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Wildman Business Group	943c8f49-e65e-40bc-b364-3274df4d21a2	2026-07-09	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	FOODHOLD U.S.A., LLC	9e09b4fb-e015-45ea-8b1c-27faf65572aa	2026-07-09	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Walgreen Company	f13fb7e9-50ea-4e2c-a442-38b1b5b315d7	2026-07-09	Warnings	Exact identifier application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60	ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETS	Health Pharma USA LLC	34eb8a9b-d0ee-13e8-e063-6294a90a2fef	2026-07-08	Warnings	Exact identifier application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg	ACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MG	Health Pharma USA LLC	3590d417-272b-ae4d-e063-6394a90a5dc6	2026-07-08	Warnings	Exact identifier application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN	ACETAMINOPHEN	Cabinet Health P.B.C.	88884253-5a79-4ac1-b8ce-03966d8b509d	2026-07-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Health Pharma USA LLC	671adabe-5f82-4599-a133-3f67ccb34079	2026-07-07	Warnings	Exact identifier application number: M013
Pain Reliever Plus	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Rugby Laboratories	c3df1652-96a8-6043-e053-2995a90a2d26	2026-07-07	Warnings	Exact identifier application number: M013
Rapidol Aspirin	ASPIRIN	Pharmadel LLC	00d9ab0d-ff25-784f-e063-6294a90a8497	2026-07-06	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Trifecta Pharmaceuticals USA LLC	227cefca-acc4-41d0-e063-6394a90a35b9	2026-07-06	Warnings	Exact identifier application number: M013
Extra Strength Pain Aid	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Hi-Tech Nutaceuticals, LLC	a39e4b99-700d-0f5c-e053-2a95a90a6bd3	2026-07-06	Warnings	Exact identifier application number: M013
Nighttime Sleep Aid	ACETAMINOPHEN, DIPHENHYDRAMINE	Hi-Tech Nutraceuticals, LLC	a39e2bd6-3d0a-642b-e053-2995a90a42a0	2026-07-06	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Hi-Tech Nutraceuticals, LLC	a36be487-7a36-550f-e053-2a95a90a95c1	2026-07-06	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Hi-Tech Nutraceuticals, LLC	a39c524e-c131-d7fb-e053-2995a90a785b	2026-07-06	Warnings	Exact identifier application number: M013
PAIN RELIEVER	ASPIRIN 81 MG	Health Pharma USA, LLC	d60aed37-3a9e-46d1-e053-2995a90a1d1f	2026-07-06	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Select Consumer Group	55d0dceb-c9a9-778e-e063-6294a90a2ad7	2026-07-04	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Select Consumer Group	3ca776c2-47ed-5107-e063-6394a90ac5df	2026-07-03	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Rugby Laboratories	f7ca9f4a-f8ef-46d2-9536-b69541e6653d	2026-07-02	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	fcd24753-b42b-4d05-8379-0ec0351ab217	8
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	fcd24753-b42b-4d05-8379-0ec0351ab217	8
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	fcd24753-b42b-4d05-8379-0ec0351ab217	8
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	fcd24753-b42b-4d05-8379-0ec0351ab217	8
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	fcd24753-b42b-4d05-8379-0ec0351ab217	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57243-501-25	57243050125	177 mL in 1 BOTTLE (57243-501-25)	177 ml	2012-01-16	0000-00-00	No	No	Current