Maxi-Tuss GMX

Product NDC
58605-312
11-digit product format
586050312
Labeler code
58605
Product ID
58605-312_4d67eeb7-1a8c-4d86-8d20-bcdb99d39326
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
MCR American Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-08-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58605-312-162022-01-28C16284748780-1d6a99b39-aab7-a426-e053-dadaa90af4c2Maxi-Tuss GMX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58605-312-16Maxi-Tuss GMX473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58605-312-16ML - Milliliter58605-312f626f75f-50cd-4c33-8dce-b2f7f143447e12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58605-312MAXI-TUSS GMX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20200801_5556850c-c6b4-48f8-b8ba-3192836c5b15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046631dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 10 mL Oral SolutionPSN5556850c-c6b4-48f8-b8ba-3192836c5b151
1046631dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML Oral SolutionSCD5556850c-c6b4-48f8-b8ba-3192836c5b151
1046631dextromethorphan HBr 10 MG / guaifenesin 200 MG per 5 ML Oral SolutionSY5556850c-c6b4-48f8-b8ba-3192836c5b151
1046631dextromethorphan HBr 20 MG / guaifenesin 400 MG per 10 ML Oral SolutionSY5556850c-c6b4-48f8-b8ba-3192836c5b151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58605-312-1658605031216473 mL in 1 BOTTLE, PLASTIC (58605-312-16) 473 ml2020-08-010000-00-00NoNoCurrent