Flu Relief Therapy

Product NDC
37808-016
11-digit product format
378080016
Labeler code
37808
Product ID
37808-016_dff28549-f650-4d7e-8ff6-6b0178c66408
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
Dosage form
LIQUID
Route
ORAL
Labeler
H E B
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-01-31
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
2020-12-31
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 productproduct37808-016DDiscontinued by firm2026-10-20
excluded packagepackage37808-01637808-016-08DDiscontinued by firm2026-10-20

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-016-082023-02-11C16284748780-1f386c649-ec12-0266-e053-dadaa90a7c1aDrug Facts
37808-016-082023-01-30C16284748780-1f386c649-ec12-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-016FLU RELIEF THERAPY DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [H E B]4Legacy NDC20230213_8981271c-3f82-4b74-a346-c933285fa1e6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-016-0837808001608245 mL in 1 BOTTLE, PLASTIC (37808-016-08) 245 ml2016-01-310000-00-00NoNoCurrent