FDA.reportPublic FDA data

NIGHTIME COLD AND FLU

Product NDC
11673-976
11-digit product format
116730976
Labeler code
11673
Product ID
11673-976_2d0e13ab-d4ec-f0cb-e063-6294a90a37c3
Type
HUMAN OTC DRUG
Nonproprietary name
NIGHTIME COLD AND FLU
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TARGET CORP
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-08
Substance
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE
Active strength
15; 325; 6.25 mg/1; mg/1; mg/1
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
NIGHTIME COLD AND FLU
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
ACETAMINOPHEN325 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
362O9ITL9DInternal UNII lookup
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094549Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9dee9b92-eac9-b07d-e053-2995a90a0602Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
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f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
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23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
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84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
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d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-976-24NIGHTIME COLD AND FLU12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED125
11673-976-24NIGHTIME COLD AND FLU2 in 1 CARTONCAPSULE, LIQUID FILLED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-976NIGHTIME COLD AND FLU CAPSULE, LIQUID FILLED [TARGET CORP]5Current NDC, Legacy NDC, 2 package rows20250215_9dee9b92-eac9-b07d-e053-2995a90a0602.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 155 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nasal decongestant maximum strength non drowsyPSEUDOEPHEDRINE HCLMeijer Distribution Inc8a68ca99-fd76-409a-9769-88830e8720a82024-09-28WarningsExact identifier
application number: M012
good neighbor pharmacy tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergen58687394-b6d2-4d51-bde0-8f2cfa3fe9092024-09-27WarningsExact identifier
application number: M012
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEAmerisource Bergenfaee3aae-e819-4084-a127-3449be353b132024-09-27WarningsExact identifier
application number: M012
Tesalon ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCLOPMX LLC2309620a-ccbc-41e9-e063-6394a90a95202024-09-26WarningsExact identifier
application number: M012
adult cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.b11c4cee-bbb5-4585-9d38-6787553e13a02024-09-26WarningsExact identifier
application number: M012
COLD AND FLU NIGHTTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9c34e-a0ca-cdf9-e053-2a95a90a93d32024-09-25WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC8f3317f6-4ae8-474b-93c3-25e256519cb82024-09-25WarningsExact identifier
application number: M012
berkley and jensen tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINBJWCb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2024-09-24WarningsExact identifier
application number: M012
Tussin DM Cough and Chest Non DrowsyDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC13eb459c-3075-4038-8062-9ee7175b2ab92024-09-24WarningsExact identifier
application number: M012
equaline nasal decongestant non drowsy maximum strengthPSEUDOEPHEDRINE HCLUnited Natural Foods, Inc. dba UNFI8897580a-709a-4643-8264-ad003d90cbff2024-09-22WarningsExact identifier
application number: M012
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLDabur India Limited22916978-303d-e62a-e063-6394a90a21002024-09-20WarningsExact identifier
application number: M012
Topcare Nasal Decongestant Maximum Strength Non DrowsyPSEUDOEPHEDRINE HCLTopco Associates LLC1a9e0336-c0c2-43f8-aeea-668d4a2097142024-09-20WarningsExact identifier
application number: M012
Leader Nasal DecongestantPSEUDOEPHEDRINE HCLCardinal Health 110, LLC. dba Leader25609b66-047c-46e7-bc95-20eb8e6c96172024-09-20WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLCVS Pharmacybebe5e78-09ba-4d35-9d34-9f5e343414782024-09-20WarningsExact identifier
application number: M012
equaline nasalPHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI67fdd277-7a7a-4404-8ca2-39802c46405f2024-09-20WarningsExact identifier
application number: M012
equaline tussinDEXTROMETHORPHAN HBR, GUAIFENESINUnited Natural Foods, Inc. dba UNFI8bc7fa7c-d565-48c9-9808-1042c3e9d4282024-09-20WarningsExact identifier
application number: M012
Leader Adult Tussin Mucus and Chest Congestion 541GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADERd7fae410-9c1c-4231-9fde-2c51ad3d7e952024-09-20WarningsExact identifier
application number: M012
sinusPSEUDOEPHEDRINE HYDROCHLORIDEKroger Company18812f2a-9b66-45a7-9631-123da6fd1c1f2024-09-20WarningsExact identifier
application number: M012
Good Sense Nasal FourPHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company930469c1-384c-4440-b3e6-9dcd674871c42024-09-19WarningsExact identifier
application number: M012
Cold and Flu Relief Multi Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWinCo Foods, LLC89272d2d-5533-4ae8-865b-cb204cec6d652024-09-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN9dee9b92-eac9-b07d-e053-2995a90a06025
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD9dee9b92-eac9-b07d-e053-2995a90a06025
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY9dee9b92-eac9-b07d-e053-2995a90a06025
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCK9def204a-ee1e-6868-e053-2995a90a76b84
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSN9def204a-ee1e-6868-e053-2995a90a76b84
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN9def204a-ee1e-6868-e053-2995a90a76b84
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN9def204a-ee1e-6868-e053-2995a90a76b84
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD9def204a-ee1e-6868-e053-2995a90a76b84
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD9def204a-ee1e-6868-e053-2995a90a76b84
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSY9def204a-ee1e-6868-e053-2995a90a76b84
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY9def204a-ee1e-6868-e053-2995a90a76b84
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY9def204a-ee1e-6868-e053-2995a90a76b84
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCK0b1dad31-ba1e-1e38-e063-6294a90a59541
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSN0b1dad31-ba1e-1e38-e063-6294a90a59541
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN0b1dad31-ba1e-1e38-e063-6294a90a59541
1867684acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral CapsulePSN0b1dad31-ba1e-1e38-e063-6294a90a59541
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN0b1dad31-ba1e-1e38-e063-6294a90a59541
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD0b1dad31-ba1e-1e38-e063-6294a90a59541
1867684acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral CapsuleSCD0b1dad31-ba1e-1e38-e063-6294a90a59541
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD0b1dad31-ba1e-1e38-e063-6294a90a59541
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSY0b1dad31-ba1e-1e38-e063-6294a90a59541
1867684acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral CapsuleSY0b1dad31-ba1e-1e38-e063-6294a90a59541
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY0b1dad31-ba1e-1e38-e063-6294a90a59541
1867684APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral CapsuleSY0b1dad31-ba1e-1e38-e063-6294a90a59541
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY0b1dad31-ba1e-1e38-e063-6294a90a59541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-976-24116730976242 BLISTER PACK in 1 CARTON (11673-976-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2020-07-080000-00-00NoNoCurrent