FDA.reportPublic FDA data

Cold and Flu

Product NDC
63868-234
11-digit product format
638680234
Labeler code
63868
Product ID
63868-234_970d9c21-b0c9-455e-993c-d333dd08245a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-31
Marketing end
2027-03-31
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

Additional Listing Data#

Finished product
Yes
Brand name base
Cold and Flu
Brand name suffix
Nighttime

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Rxcui1043400

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-234-082023-05-10C16284748780-1f386c64a-02e7-0266-e053-dadaa90a7c1aDrug Facts
63868-234-122023-05-10C16284748780-1f386c64a-02e7-0266-e053-dadaa90a7c1aDrug Facts
63868-234-082023-01-30C16284748780-1f386c64a-02e7-0266-e053-dadaa90a7c1aDrug Facts
63868-234-122023-01-30C16284748780-1f386c64a-02e7-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-234-08Cold and FluNighttime237 mL in 1 BOTTLE, PLASTICLIQUID2378
63868-234-12Cold and FluNighttime355 mL in 1 BOTTLE, PLASTICLIQUID3558

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-234-08ML - Milliliter63868-234c220f551-0dc7-44f3-8f63-6a077c7855b612022-10-06
63868-234-12ML - Milliliter63868-234c7961ede-03a9-4755-9ef9-9492c55d4aaf12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-234COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]7Current NDC, Legacy NDC, 2 package rows20240502_e70d0784-53bc-4910-aade-3c9ad6e36441.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNe70d0784-53bc-4910-aade-3c9ad6e364418
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDe70d0784-53bc-4910-aade-3c9ad6e364418
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYe70d0784-53bc-4910-aade-3c9ad6e364418
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYe70d0784-53bc-4910-aade-3c9ad6e364418
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYe70d0784-53bc-4910-aade-3c9ad6e364418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-234-0863868023408237 mL in 1 BOTTLE, PLASTIC (63868-234-08) 237 ml2016-08-312027-03-31NoNoCurrent
63868-234-1263868023412355 mL in 1 BOTTLE, PLASTIC (63868-234-12) 355 ml2016-08-312027-03-31NoNoCurrent