Night Time Cold and Flu

Product NDC: 49580-0343
11-digit product format: 495800343
Labeler code: 49580
Product ID: 49580-0343_6b8c5604-2fc0-4acb-a71e-0a9ae331fd4e
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form: LIQUID
Route: ORAL
Labeler: P & L Development, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-10-31
Marketing end: 2026-12-31
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
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	49580-0343-8
excluded package	package	49580-0343-4
excluded package	package	49580-0343-6
excluded package	package	49580-0343-2

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: Night Time Cold and Flu
Brand name suffix: ReadyInCase

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
e7dd763b-3005-4723-933b-171eb772afee	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
49580-0343-2	2023-05-24	Drug Facts
49580-0343-2	2023-05-24	Drug Facts
49580-0343-4	2023-05-24	Drug Facts
49580-0343-4	2023-05-24	Drug Facts
49580-0343-6	2023-05-24	Drug Facts
49580-0343-6	2023-05-24	Drug Facts
49580-0343-8	2023-05-24	Drug Facts
49580-0343-8	2023-05-24	Drug Facts
49580-0343-2	2023-01-30	Drug Facts
49580-0343-2	2023-01-30	Drug Facts
49580-0343-4	2023-01-30	Drug Facts
49580-0343-4	2023-01-30	Drug Facts
49580-0343-6	2023-01-30	Drug Facts
49580-0343-6	2023-01-30	Drug Facts
49580-0343-8	2023-01-30	Drug Facts
49580-0343-8	2023-01-30	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49580-0343-2	Night Time Cold and FluReadyInCase	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355	13
49580-0343-4	Night Time Cold and FluReadyInCase	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118	13
49580-0343-6	Night Time Cold and FluReadyInCase	177 mL in 1 BOTTLE, PLASTIC	LIQUID	177	13
49580-0343-8	Night Time Cold and FluReadyInCase	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237	13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49580-0343	NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC]	11	Current NDC, Legacy NDC, 4 package rows	20241211_e7dd763b-3005-4723-933b-171eb772afee.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 85 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	323347c3-d51a-4976-e063-6294a90a952e	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	WALGREEN COMPANY	2969ba8f-c477-222a-e063-6394a90af703	2025-12-01	Warnings	Exact identifier application number: M012
CareAll Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS	New World Imports, Inc	4cd2f751-e072-4f4e-b059-ed1dfcc60c6b	2025-12-01	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY, INC	bbb1b395-48d9-4859-ad52-6650961089d9	2025-12-01	Warnings	Exact identifier application number: M012
Severe Sinus Pain and Congestion	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	fbc541ac-9465-4296-bb1e-811b9d811f40	2025-11-26	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Grocery Outlet, Inc.	447951e6-459d-0a52-e063-6294a90a6226	2025-11-26	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	WALGREENS CO.	bfc58cd5-9815-43af-895d-ec6cbd10937e	2025-11-26	Warnings	Exact identifier application number: M012
Walgreen Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	WALGREEN COMPANY	40c038a3-91c7-4ed0-8210-65d58b82ca2b	2025-11-26	Warnings	Exact identifier application number: M012
Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	WALGREENS CO	724554ab-60b8-46c8-96a8-a98242604e3b	2025-11-26	Warnings	Exact identifier application number: M012
Walgreens Grape Flavor	CHILDREN COUGH AND CHEST CONGESTION	WALGREENS	795cf1af-3847-46bc-b605-64a38e57cca2	2025-11-26	Warnings	Exact identifier application number: M012
Walgreens	CHILDRENS STUFFY NOSE AND COLD	WALGREENS CO.	7ac3de2d-1d10-49ec-a2da-da46977684ad	2025-11-26	Warnings	Exact identifier application number: M012
Childrens Chest Congestion Relief	GUAIFENESIN	WALGREENS COMPANY	c1382512-e6f3-4bdf-a9e6-4f68dd5ea553	2025-11-26	Warnings	Exact identifier application number: M012
Dye Free Wal Sleep Z	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN CO.	96948973-09e3-4c05-8982-0494ebeaac4b	2025-11-26	Warnings	Exact identifier application number: M012
WALGREEN ADULT COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	WALGREEN COMPANY	02ad9f98-07ad-4786-a1ab-169b870fec01	2025-11-26	Warnings	Exact identifier application number: M012
Walgreen Cherry	GUAIFENESIN	WALGREEN COMPANY	1f1cb4a5-1ebd-483c-bf82-16931da00e05	2025-11-26	Warnings	Exact identifier application number: M012
Walgreen Childrens COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	801880b2-6116-4d26-a7bf-a669eef6ad8b	2025-11-26	Warnings	Exact identifier application number: M012
Walgreen Daytimel Kids Cold Cough plus Mucus	GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	452159e0-1204-460c-981f-cace4e815c6f	2025-11-26	Warnings	Exact identifier application number: M012
Multi Symptom Wal Flu Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	WALGREEN CO.	9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb	2025-11-25	Warnings	Exact identifier application number: M012
WALGREEN Daytime Multi Symptom Flu Relief Max Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	WALGREENS CO.	c92a0f47-0b7c-4034-83d1-b7d2ed8022fc	2025-11-25	Warnings	Exact identifier application number: M012
Mucus Relief DM Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	WALGREENS CO.	428081f5-b7eb-42da-963c-a587a44b2a79	2025-11-25	Warnings	Exact identifier application number: M012

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	e7dd763b-3005-4723-933b-171eb772afee	13
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	e7dd763b-3005-4723-933b-171eb772afee	13
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	e7dd763b-3005-4723-933b-171eb772afee	13
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	e7dd763b-3005-4723-933b-171eb772afee	13
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	e7dd763b-3005-4723-933b-171eb772afee	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49580-0343-2	49580034302	355 mL in 1 BOTTLE, PLASTIC (49580-0343-2)	355 ml	2014-10-31	2026-12-31	No	No	Current
49580-0343-4	49580034304	118 mL in 1 BOTTLE, PLASTIC (49580-0343-4)	118 ml	2014-10-31	2026-12-31	No	No	Current
49580-0343-6	49580034306	177 mL in 1 BOTTLE, PLASTIC (49580-0343-6)	177 ml	2014-10-31	2026-12-31	No	No	Current
49580-0343-8	49580034308	237 mL in 1 BOTTLE, PLASTIC (49580-0343-8)	237 ml	2014-10-31	2026-12-31	No	No	Current