Nite-TimeCOLD/FLU CHERRY

Product NDC: 57243-502
11-digit product format: 572430502
Labeler code: 57243
Product ID: 57243-502_21dee833-1f0b-4ac7-a662-169dc2fc6d0a
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: 2012-01-31
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-TimeCOLD/FLU CHERRY
Brand name suffix: COLD/FLU CHERRY
Listing expiration: 2027-12-31

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
e6c3e545-b2ad-47f0-8318-c134a8e24f5b	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
57243-502-25	Nite-TimeCOLD/FLU CHERRYCOLD/FLU CHERRY	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-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (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
57243-502	NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20231230_e6c3e545-b2ad-47f0-8318-c134a8e24f5b.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 66 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	2024-07-02	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN	Discount Drug Mart Inc	1c35f394-a221-6531-e063-6394a90acb8a	2024-07-01	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Wildman Business Group	cdbfcf14-8685-40a9-9778-a3b4329dc1ad	2024-07-01	Warnings	Exact identifier application number: M013
Back Pain Relief Extra Strength Doans	MAGNESIUM SALICYLATE	Wildman Business Group	2e17664f-a83f-48d1-8b2b-37f41eea65b6	2024-07-01	Warnings	Exact identifier application number: M013
Meijer Effervescent Pain Relief	ASPIRIN	Meijer Distribution Inc	17553911-e0fc-e355-e063-6394a90af7b8	2024-06-28	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4fb4f4b2-c238-4933-b874-08def3b34a28	2024-06-26	Warnings	Exact identifier application number: M013
good neighbor pharmacy pain and fever childrens	ACETAMINOPHEN	Amerisource Bergen	ca0833ef-837b-47dc-8676-e016af96622c	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4a030c3e-8104-4a0a-98c5-6ab469451f20	2024-06-26	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	a426dd82-b2d6-405e-b0af-cfb1310a6e19	2024-06-26	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALMART INC. (see also Equate)	7d86a03f-74f4-4b24-b6a6-8747acfe905e	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	5bcc5da9-7e64-4308-a5be-2f47a8ca774d	2024-06-25	Warnings	Exact identifier application number: M013
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	NuCare Pharmaceuticals,Inc.	9e691264-d48a-6b48-e053-2995a90a9352	2024-06-20	Warnings	Exact identifier application number: M013
Aspirin	REGULAR STRENGTH ENTERIC COATED ASPIRIN	NuCare Pharmceuticals,Inc.	a0705f4f-55cb-214a-e053-2995a90aa680	2024-06-20	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG	Lil' Drug Store Products, Inc.	ee8e0e79-4da4-101f-e053-2a95a90a30a4	2024-06-19	Warnings	Exact identifier application number: M013
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil' Drug Store Products, Inc.	b3a06e4b-0b31-4e2a-8dd1-9de85760477b	2024-06-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	43c3fe72-a4ef-48a6-bc22-a644919c0c5c	2024-06-17	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	093182a6-3ed8-5a3f-e063-6294a90a354a	2024-06-14	Warnings	Exact identifier application number: M013
ACETAMINOPHEN PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	093199be-e92a-6f60-e063-6294a90a8533	2024-06-14	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	09315a3d-bb2d-4f06-e063-6294a90a3bd3	2024-06-14	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	613bc633-0426-41a7-aea9-9ff56311b607	2024-06-13	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	e6c3e545-b2ad-47f0-8318-c134a8e24f5b	8
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	e6c3e545-b2ad-47f0-8318-c134a8e24f5b	8
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	e6c3e545-b2ad-47f0-8318-c134a8e24f5b	8
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	e6c3e545-b2ad-47f0-8318-c134a8e24f5b	8
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	e6c3e545-b2ad-47f0-8318-c134a8e24f5b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57243-502-25	57243050225	177 mL in 1 BOTTLE (57243-502-25)	177 ml	2012-01-31	0000-00-00	No	No	Current