FDA.reportPublic FDA data

Cough Mucus Relief DM

Product NDC
70692-101
11-digit product format
706920101
Labeler code
70692
Product ID
70692-101_b193b6ae-555b-7d3e-e053-2a95a90a6814
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Strive Pharmaceuticals Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-02-15
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
400 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70692-101IInactivated by FDA2026-07-31
excluded packagepackage70692-10170692-101-24IInactivated by FDA2026-07-31
excluded packagepackage70692-10170692-101-41IInactivated by FDA2026-07-31

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
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
70692-101-242022-01-28C16284748780-1d6a99b39-9691-a426-e053-dadaa90af4c2Dextromethorphan HBr 20mg and Guaifenesin 400mg
70692-101-412022-01-28C16284748780-1d6a99b39-9691-a426-e053-dadaa90af4c2Dextromethorphan HBr 20mg and Guaifenesin 400mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-101-24Cough Mucus Relief DM24 in 1 BOTTLETABLET244
70692-101-41Cough Mucus Relief DM4 in 1 PACKAGETABLET44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-101COUGH MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET [STRIVE PHARMACEUTICALS INC.]4Legacy NDC, 2 package rows20201014_6878aed8-df32-19f1-e053-2991aa0a614e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN6878aed8-df32-19f1-e053-2991aa0a614e4
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD6878aed8-df32-19f1-e053-2991aa0a614e4
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY6878aed8-df32-19f1-e053-2991aa0a614e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70692-101-247069201012424 TABLET in 1 BOTTLE (70692-101-24) 24 tablet2018-02-150000-00-00NoNoCurrent
70692-101-41706920101414 TABLET in 1 PACKAGE (70692-101-41) 4 tablet2018-12-200000-00-00NoNoCurrent