FDA.reportPublic FDA data

Childrens Robitussin 12 Hour Cough Relief

Product NDC
0031-8726
11-digit product format
000318726
Labeler code
0031
Product ID
0031-8726_159adf0d-831e-3d0e-e063-6394a90a40dd
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
ANDA091135
Marketing category
ANDA
Marketing start
2016-07-05
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 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
Childrens Robitussin 12 Hour Cough Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1373045

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8726-10Childrens Robitussin 12 Hour Cough Relief89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE899
0031-8726-10Childrens Robitussin 12 Hour Cough Relief1 in 1 CARTONSUSPENSION, EXTENDED RELEASE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8726-10ML - Milliliter0031-8726552dff76-9050-47df-8799-ef2e88f079b712017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8726CHILDRENS ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 2 package rows20240410_6bcad434-5714-443c-ba83-ed534df9f20a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN6bcad434-5714-443c-ba83-ed534df9f20a9
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD6bcad434-5714-443c-ba83-ed534df9f20a9
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY6bcad434-5714-443c-ba83-ed534df9f20a9
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY6bcad434-5714-443c-ba83-ed534df9f20a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8726-10000318726101 BOTTLE in 1 CARTON (0031-8726-10) / 89 mL in 1 BOTTLE1 bottle2016-07-050000-00-00NoNoCurrent