FDA.reportPublic FDA data

Severe Cold and Cough

Product NDC
36800-316
11-digit product format
368000316
Labeler code
36800
Product ID
36800-316_9743932c-64b4-49ae-a848-b2627f4f0a36
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
Dosage form
LIQUID
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-11-30
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-316DDiscontinued by firm2026-10-05
excluded packagepackage36800-31636800-316-08DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-316SEVERE COLD AND COUGH DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]5Legacy NDC20231014_c6475e58-5152-4dad-be2f-4ca32b8589d7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-316-0836800031608245 mL in 1 BOTTLE, PLASTIC (36800-316-08) 245 ml2015-11-300000-00-00NoNoCurrent