Nighttime Cold and Flu Relief

Product NDC: 21130-343
11-digit product format: 211300343
Labeler code: 21130
Product ID: 21130-343_f9779d0d-b679-494a-919f-b5b540423f0c
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form: LIQUID
Route: ORAL
Labeler: Safeway, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-06-30
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: Nighttime Cold and Flu Relief
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
a70ead03-6d2c-44c1-9ae5-f6c4094821ec	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	SPL version
21130-343-08	Nighttime Cold and Flu Relief	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237	8
21130-343-12	Nighttime Cold and Flu Relief	355 mL in 1 BOTTLE	LIQUID	355	8
21130-343-24	Nighttime Cold and Flu Relief	2 in 1 PACKAGE	LIQUID	2	8
21130-343-24	Nighttime Cold and Flu Relief	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355	8

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-343	NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.]	8	Current NDC, Legacy NDC, 4 package rows	20240515_a70ead03-6d2c-44c1-9ae5-f6c4094821ec.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 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS PHARMACY	3148f80f-8a0d-4b6c-85be-79085fc04444	2026-08-19	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	aa7164a7-f842-457d-abee-0740bb8c1c90	2026-08-19	Warnings	Exact identifier application number: M012
CVS	CHILDRENS STUFFY NOSE AND COLD	CVS PHARMACY, INC	6cff265d-94a3-4617-a366-fe970d97f05a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Congestion and Pain Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS	5a8e4320-bae1-4831-b66b-9babfe8888d6	2026-08-19	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	CVS PHARMACY	0ae0c244-e019-4b35-890c-8e15e3d3f7ce	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	e32881f5-2bb5-4756-aa86-a09473ab590b	2026-08-19	Warnings	Exact identifier application number: M012
Good Sense Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	L. Perrigo Company	d2541ef0-a73c-43aa-91ff-fdbce2748c4f	2026-08-18	Warnings	Exact identifier application number: M012
CVS Severe Nasal Congestion Relief Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	5a7e42ee-810c-4bc1-9d8d-fac8e849e126	2026-08-18	Warnings	Exact identifier application number: M012
DAYTIME NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	8dd039b4-209a-484a-b15e-741d55087a93	2026-08-18	Warnings	Exact identifier application number: M012
CVS Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	CVS PHARMACY	558b7ed6-a9f6-452c-90cd-df8258663bf1	2026-08-18	Warnings	Exact identifier application number: M012
Extra Strength Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	7acf1a9a-bd97-48bb-8025-ac26070378a2	2026-08-18	Warnings	Exact identifier application number: M012
Polytussin DM	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE	Poly Pharmaceuticals, Inc.	fda8f594-82bf-1781-e053-6294a90ad344	2026-08-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	da1f1ef9-a974-4998-8e1d-c1d999596943	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	89168715-71b1-424e-8dae-fcfa90bc85bf	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Sinus	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	c7840511-3a4f-4547-ae90-19b085a5874e	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health	NASAL OXYMETAZOLINE HCL	CVS Pharmacy,Inc.	56f08e70-bf16-4933-97bc-177bc190d12a	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health No Drip	ALLERGY NASAL	CVS PHARMACY,INC.	3e76ffac-07a7-4b6a-bc4c-9cabb653e064	2026-08-17	Warnings	Exact identifier application number: M012
CVS dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	2026-08-17	Warnings	Exact identifier application number: M012
CVS Overnight Cold and Flu Clear and Cool	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	CVS PHARMACY, INC	2497a011-d7a0-4d69-97e2-bbf25a99b1cc	2026-08-17	Warnings	Exact identifier application number: M012
Mucus Relief Cough Cold Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	3ef949f5-ac8c-44be-b04d-6996fa59a94b	2026-08-17	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	a70ead03-6d2c-44c1-9ae5-f6c4094821ec	8
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	a70ead03-6d2c-44c1-9ae5-f6c4094821ec	8
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	a70ead03-6d2c-44c1-9ae5-f6c4094821ec	8
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	a70ead03-6d2c-44c1-9ae5-f6c4094821ec	8
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	a70ead03-6d2c-44c1-9ae5-f6c4094821ec	8
2637726	{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } Pack	GPCK	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
2637726	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) Pack	PSN	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
2637726	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) Pack	SY	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	f762600a-f4b1-4869-a04b-8431c3d8a3e3	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-343-08	21130034308	237 mL in 1 BOTTLE, PLASTIC (21130-343-08)	237 ml	2014-06-30	0000-00-00	No	No	Current
21130-343-12	21130034312	355 mL in 1 BOTTLE (21130-343-12)	355 ml	2014-06-30	0000-00-00	No	No	Current
21130-343-24	21130034324	2 BOTTLE, PLASTIC in 1 PACKAGE (21130-343-24) / 355 mL in 1 BOTTLE, PLASTIC		2014-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Safeway, Inc.	2024-05-14	HUMAN OTC DRUG LABEL	8
Drug Facts	Safeway, Inc.	2024-05-13	HUMAN OTC DRUG LABEL	6