NDC 55316-012

Nighttime Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

Nighttime Cold and Flu is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Dza Brands Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

Product ID55316-012_324e3f1d-d80c-4ecf-a7c4-bb375b11d91c
NDC55316-012
Product TypeHuman Otc Drug
Proprietary NameNighttime Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2017-03-08
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDZA Brands LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55316-012-14

2 BLISTER PACK in 1 CARTON (55316-012-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2017-03-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-012-14 [55316001214]

Nighttime Cold and Flu CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-08

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:84143135-cce5-4bb2-9303-4ac82b5c2507
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1297288

    • NDC Crossover Matching brand name "Nighttime Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-0460Nighttime Cold and FluAcetaminophen, Diphenhydramine HCI, Phenylephrine HCI
    0363-0850Nighttime Cold and FluAcetaminophen Dextromethorphan HBr Doxylamine succinate
    0363-1011NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
    0363-1141nighttime cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
    0363-9975Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    0363-9976Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    11673-460Nighttime Cold and FluAcetaminophen, Diphenhydramine HCI, Phenylephrine HCI
    70005-005NIGHTTIME COLD AND FLUNIGHTTIME COLD AND FLU
    76168-056NightTime Cold and FluNightTime Cold and Flu
    37012-335Nighttime Cold and FluNighttime Cold and Flu
    37835-952NIGHTTIME COLD AND FLUNIGHTTIME COLD AND FLU
    49035-041Nighttime Cold and FluNighttime Cold and Flu
    49348-157Nighttime cold and fluNighttime cold and flu
    49738-480Nighttime cold and fluNighttime cold and flu
    50804-480Nighttime cold and fluNighttime cold and flu
    51013-193Nighttime Cold and FluNighttime Cold and Flu
    51013-147NIGHTTIME COLD and FLUNIGHTTIME COLD and FLU
    51013-131NIGHTTIME COLD and FLUNIGHTTIME COLD and FLU
    53345-006Nighttime Cold and FluNighttime Cold and Flu
    53441-342Nighttime Cold and FluNighttime Cold and Flu
    53441-346Nighttime Cold and FluNighttime Cold and Flu
    53345-026Nighttime Cold and FluNighttime Cold and Flu
    53441-343Nighttime Cold and FluNighttime Cold and Flu
    55316-012Nighttime Cold and FluNighttime Cold and Flu
    63868-219Nighttime Cold and FluNighttime Cold and Flu
    46994-344Nighttime Cold and FluNighttime Cold and Flu
    11822-3318Nighttime Cold and FluNighttime Cold and Flu
    66715-6716Nighttime Cold and FluNighttime Cold and Flu
    66715-6816Nighttime Cold and FluNighttime Cold and Flu
    41250-586NightTime Cold and FluNightTime Cold and Flu
    0280-1580Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1581Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1600Alka-Seltzer Plus Maximum Strength Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1640Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gelsacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0280-1610Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and NightAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1620Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and CoughAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0280-1222Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels NightAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
    0113-7501basic care nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0113-7763basic care nigttime cold and flu severeAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    11822-0591cold and flu reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    0363-1658Dye Free Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    0363-5900nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
    11673-763up and up nighttime severe cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
    11673-251up and up nighttime vapor ice cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
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