FDA.reportPublic FDA data

Basic Care Severe Cold and Flu

Product NDC
72288-303
11-digit product format
722880303
Labeler code
72288
Product ID
72288-303_2b64c1cb-da06-460b-9f0f-fe49b1f69b46
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Amazon.com Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-11
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
500; 20; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Basic Care Severe Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1189316

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-303-91Basic Care Severe Cold and Flu6 in 1 CARTONPOWDER, FOR SOLUTION63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-303BASIC CARE SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 1 package rows20241105_968c605e-fea3-4c79-b650-6021aa17db7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSN968c605e-fea3-4c79-b650-6021aa17db7a3
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCD968c605e-fea3-4c79-b650-6021aa17db7a3
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSY968c605e-fea3-4c79-b650-6021aa17db7a3
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSY968c605e-fea3-4c79-b650-6021aa17db7a3
1189316APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSY968c605e-fea3-4c79-b650-6021aa17db7a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72288-303-91722880303916 POWDER, FOR SOLUTION in 1 CARTON (72288-303-91) 2021-08-110000-00-00NoNoCurrent