FDA.reportPublic FDA data

Signature Care Cough Relief

Product NDC
21130-520
11-digit product format
211300520
Labeler code
21130
Product ID
21130-520_5d7aec7b-44b4-4cdc-8361-fa19bdb74c65
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Safeway
Application
ANDA091135
Marketing category
ANDA
Marketing start
2021-07-08
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
Signature Care 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-520-21Signature Care Cough Relief1 in 1 CARTONSUSPENSION, EXTENDED RELEASE12
21130-520-21Signature Care Cough Relief89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-520SIGNATURE CARE COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [SAFEWAY]2Current NDC, Legacy NDC, 2 package rows20210717_f95d0519-e96b-45fe-974c-8fe6b9b8c88c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNf95d0519-e96b-45fe-974c-8fe6b9b8c88c2
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDf95d0519-e96b-45fe-974c-8fe6b9b8c88c2
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYf95d0519-e96b-45fe-974c-8fe6b9b8c88c2
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYf95d0519-e96b-45fe-974c-8fe6b9b8c88c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-520-21211300520211 BOTTLE in 1 CARTON (21130-520-21) / 89 mL in 1 BOTTLE1 bottle2021-07-080000-00-00NoNoCurrent