Giltuss Honey DM Cough

Product NDC
58552-143
11-digit product format
585520143
Labeler code
58552
Product ID
58552-143_40b8f3ae-f0b1-deb3-e063-6294a90a1fec
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr
Dosage form
SOLUTION
Route
ORAL
Labeler
Gil Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-22
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/10mL
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
Giltuss Honey DM Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1090496

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58552-143-042022-01-30C16284748780-1d6a99b39-4176-a426-e053-dadaa90af4c2Giltuss Honey DM
58552-143-042022-01-30C16284748780-1d6a99b39-4176-a426-e053-dadaa90af4c2Giltuss Honey DM
58552-143-042022-01-28C16284748780-1d6a99b39-4176-a426-e053-dadaa90af4c2Giltuss Honey DM
58552-143-042022-01-28C16284748780-1d6a99b39-4176-a426-e053-dadaa90af4c2Giltuss Honey DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-143-04Giltuss Honey DM Cough118 mL in 1 BOTTLESOLUTION1186
58552-143-04Giltuss Honey DM Cough1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-143-04ML - Milliliter58552-143774e501c-3fd4-4ec9-91a0-21a5e471011512022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-143GILTUSS HONEY DM COUGH (DEXTROMETHORPHAN HBR) SOLUTION [GIL PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20241027_a8c08532-1169-6603-e053-2a95a90a3484.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSNa8c08532-1169-6603-e053-2a95a90a34846
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCDa8c08532-1169-6603-e053-2a95a90a34846
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSYa8c08532-1169-6603-e053-2a95a90a34846
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSYa8c08532-1169-6603-e053-2a95a90a34846

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58552-143-04585520143041 BOTTLE in 1 CARTON (58552-143-04) / 118 mL in 1 BOTTLE1 bottle2020-06-220000-00-00NoNoCurrent