FDA.reportPublic FDA data

Father Johns Medicine

Product NDC
45728-444
11-digit product format
457280444
Labeler code
45728
Product ID
45728-444_0ccb64df-0691-12f4-e063-6294a90aca99
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
Oakhurst Company
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Father Johns Medicine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui2373441

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45728-444-94Father Johns Medicine118 mL in 1 CONTAINERLIQUID1186
45728-444-94Father Johns Medicine1 in 1 CARTONLIQUID16
45728-444-98Father Johns Medicine1 in 1 CONTAINERLIQUID16
45728-444-98Father Johns Medicine237 mL in 1 CONTAINERLIQUID2376

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45728-444FATHER JOHNS MEDICINE (DEXTROMETHORPHAN HBR) LIQUID [OAKHURST COMPANY]6Current NDC, Legacy NDC, 4 package rows20231219_8b8a249d-55af-cc98-e053-2995a90a431d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2373441dextromethorphan HBr 10 MG in 5 mL Oral SuspensionPSN8b8a249d-55af-cc98-e053-2995a90a431d6
2373441dextromethorphan hydrobromide 2 MG/ML Oral SuspensionSCD8b8a249d-55af-cc98-e053-2995a90a431d6
2373441dextromethorphan HBr 10 MG per 5 ML Oral SuspensionSY8b8a249d-55af-cc98-e053-2995a90a431d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45728-444-94457280444941 CONTAINER in 1 CARTON (45728-444-94) / 118 mL in 1 CONTAINER1 container2019-06-170000-00-00NoNoCurrent
45728-444-98457280444981 CONTAINER in 1 CONTAINER (45728-444-98) / 237 mL in 1 CONTAINER1 container2019-06-170000-00-00NoNoCurrent