Home NDC 0395-9126 Father Johns Medicine
Product NDC 0395-9126
11-digit product format 003959126
Labeler code 0395
Product ID 0395-9126_0c9368f8-3985-07dd-e063-6394a90ac66a
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr
Dosage form LIQUID
Route ORAL
Labeler Humco Holding Group, Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-17
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 10 mg/5mL
Pharmacologic classes 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
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Father Johns Medicine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2373441 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0395-9126-94 Father Johns Medicine 118 mL in 1 CONTAINER LIQUID 118 4 0395-9126-94 Father Johns Medicine 1 in 1 CARTON LIQUID 1 4 0395-9126-98 Father Johns Medicine 237 mL in 1 CARTON LIQUID 237 4 0395-9126-98 Father Johns Medicine 1 in 1 CARTON LIQUID 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-9126 FATHER JOHNS MEDICINE (DEXTROMETHORPHAN HBR) LIQUID [HUMCO HOLDING GROUP, INC] 4 Current NDC, Legacy NDC, 4 package rows 20231216_a7b0669f-8da1-5a44-e053-2995a90a84d9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 96 of 177 · 3,534 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0395-9126-94 00395912694 1 CONTAINER in 1 CARTON (0395-9126-94) / 118 mL in 1 CONTAINER 1 container 2019-06-17 0000-00-00 No No Current 0395-9126-98 00395912698 1 CARTON in 1 CARTON (0395-9126-98) / 237 mL in 1 CARTON 1 carton 2019-06-17 0000-00-00 No No Current