MMM - Cough Formula Guaifenesin DM

Product NDC
69822-021
Requested package NDC
69822-021-40
11-digit product format
698220021
Labeler code
69822
Product ID
69822-021_cc1fc608-d204-b9eb-e053-2a95a90aa1f5
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin DM
Dosage form
LIQUID
Route
ORAL
Labeler
Southern Sales & Services, Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
100 mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69822-021-402023-01-30C16284748780-1f386c64a-299c-0266-e053-dadaa90a7c1aMMM Cough Formula Guaifenesin DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-021-40MMM - Cough Formula Guaifenesin DM118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-021MMM - COUGH FORMULA GUAIFENESIN DM (GUAIFENESIN DM) LIQUID [SOUTHERN SALES & SERVICES, INC]1Legacy NDC, 1 package rows20210923_cc1fc608-d203-b9eb-e053-2a95a90aa1f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNcc1fc608-d203-b9eb-e053-2a95a90aa1f51
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDcc1fc608-d203-b9eb-e053-2a95a90aa1f51
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYcc1fc608-d203-b9eb-e053-2a95a90aa1f51
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYcc1fc608-d203-b9eb-e053-2a95a90aa1f51
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYcc1fc608-d203-b9eb-e053-2a95a90aa1f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69822-021-4069822002140118 mL in 1 BOTTLE (69822-021-40) 118 ml2021-01-010000-00-00NoNoCurrent