FDA.reportPublic FDA data

Night Time Cold and Flu Relief

Product NDC
63868-418
11-digit product format
638680418
Labeler code
63868
Product ID
63868-418_619d899d-f96e-40c3-a11d-441ef6522150
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-30
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325; 15; 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

Additional Listing Data#

Finished product
Yes
Brand name base
Night Time Cold and Flu Relief
Brand name suffix
Multi Symptom
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Rxcui1094549

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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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
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
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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
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f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
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7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-418-24Night Time Cold and Flu ReliefMulti Symptom24 in 1 CARTONCAPSULE, LIQUID FILLED243
63868-418-24Night Time Cold and Flu ReliefMulti Symptom1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-418-24EA - Each63868-41820829af5-5afe-45f1-a6ec-80dff263e79812022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-418NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Current NDC, Legacy NDC, 2 package rows20240502_07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a3
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a3
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-418-246386804182424 BLISTER PACK in 1 CARTON (63868-418-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 blister pack2019-08-300000-00-00NoNoCurrent