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: 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: 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 15 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin 81 mg Low Dose	ASPIRIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	23b29044-6389-42ea-839a-5351557a6ce3	2026-04-23	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4a70867e-481d-4f01-9da3-d85663a1672e	2026-04-23	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	07edcb31-d31d-4607-98c3-dcb1e062cc70	2026-04-22	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	ee50c5ee-1a61-4efc-aca9-42d897d6a3b8	2026-04-22	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	CVS PHARMACY	904a2b21-d911-40c3-9e4b-59543ea5be4f	2026-04-22	Warnings	Exact identifier application number: M013
Pamprin Multi-Symptom Maximum Strength	ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE	Focus Consumer Healthcare, LLC	60b3286d-5698-df50-e053-2991aa0afbe2	2026-04-20	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	CVS PHARMACY	af6fe4a9-2d18-4fed-b952-0a7866f65251	2026-04-20	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Preferred Pharmaceuticals Inc.	ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e	2026-04-20	Warnings	Exact identifier application number: M013
Parry-500mg Acetaminophen	ACETAMINOPHEN	MDC PHARMACEUTICALS LIMITED	fb07ba10-3210-41bc-9310-c952118fdcf3	2026-04-17	Warnings	Exact identifier application number: M013
Aspirin NSAID	ASPIRIN	Valu Merchandisers Company	0cc46a81-54c9-44b7-b384-79d25255eff2	2026-04-17	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Valu Merchandisers Company	99de2c41-59b0-42e7-847e-e51229c6164f	2026-04-17	Warnings	Exact identifier application number: M013
Pain and Fever Childrens	ACETAMINOPHEN	Walgreen Company	1f3e2895-5ef7-4e6a-8d2e-b805d148f980	2026-04-16	Warnings	Exact identifier application number: M013
Childrens TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	b297aff8-a08b-4d37-b168-800a56564cbd	2026-04-16	Warnings	Exact identifier application number: M013
Childrens Tylenol	ACETAMINOPHEN	Kenvue Brands LLC	9782fe86-d72a-4231-b1ba-d3f3b4ee49e3	2026-04-16	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	8e65478b-7a7b-416c-b8e3-23dad79f8cc1	2026-04-16	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Valu Merchandisers Company	c9e384e5-fa9b-4c75-b5e3-16eb8db662ef	2026-04-16	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	b6abfbbb-9826-4cd6-940f-3a314480a5a5	2026-04-15	Warnings	Exact identifier application number: M013
Good Sense Pain and Fever	ACETAMINOPHEN	L. Perrigo Company	f7137fe6-582e-43a4-8302-90ca54cd1de3	2026-04-14	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	e13656eb-513e-411e-bdae-35ff1ba7cfc1	2026-04-13	Warnings	Exact identifier application number: M013
CareOne Acetaminophen	ACETAMINOPHEN	American Sales Company	b4f54465-3232-4685-9570-90be00876577	2026-04-12	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