MGC Health

Product NDC
83173-117
11-digit product format
831730117
Labeler code
83173
Product ID
83173-117_3de65c99-6c30-3650-e063-6394a90aa98c
Type
HUMAN OTC DRUG
Nonproprietary name
Cough Drops Assorted Citrus Vitamin C Sugar-Free
Dosage form
TABLET, CHEWABLE, EXTENDED RELEASE
Route
ORAL
Labeler
Medical Group Care LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-12
Substance
MENTHOL
Active strength
2.7 mg/2850mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage83173-117-25IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage83173-117-25IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage83173-117-25IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage83173-117-25IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage83173-117-25IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage83173-117-25UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83173-117-25UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83173-117-25UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
MGC Health
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.7 mg/2850mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4a9d879-4736-4f63-e053-2995a90adebaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83173-117-25MGC Health25 in 1 BAGTABLET, CHEWABLE, EXTENDED RELEA253
83173-117-25MGC Health2.7 mg in 1 DOSE PACKTABLET, CHEWABLE, EXTENDED RELEA2.73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83173-117MGC HEALTH (COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE) TABLET, CHEWABLE, EXTENDED RELEASE [MEDICAL GROUP CARE LLC]2Current NDC, 2 package rows20230227_f4a9d879-4736-4f63-e053-2995a90adeba.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 173 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AkinGUAIFENESINSouthern Sales & Service, Inc.bb2c9f21-6765-4286-bd71-de01cdf4c4e92023-11-29WarningsExact identifier
application number: M012
Akin Cough Formula DMDEXTROMETHORPHAN, GUAIFENESINSouthern Sales & Service, Inc.1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a2023-11-29WarningsExact identifier
application number: M012
diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESimpex Pharma Pvt. Ltd82771f6a-8b3d-4ffa-8b35-09c2faf3582c2023-11-29WarningsExact identifier
application number: M012
SIMPEX GuaifenesinGUAIFENESINSimpex Pharma Pvt. Ltd1594f9d6-0c48-42bf-b76b-d621f215179a2023-11-29WarningsExact identifier
application number: M012
StonaACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.8b89f50d-88f8-4773-92ea-5ada617660562023-11-28WarningsExact identifier
application number: M012
StonaDEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.1ccc9e56-32a4-450f-8412-5814b6aef2852023-11-28WarningsExact identifier
application number: M012
Neo-Synephrine MaximumPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab8682a4-1f66-6709-e053-2995a90a8b4a2023-11-16WarningsExact identifier
application number: M012
Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab860c10-b8cf-3f92-e053-2a95a90a73172023-11-16WarningsExact identifier
application number: M012
Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC9b8e9162-e4da-14d9-e053-2995a90a22692023-11-16WarningsExact identifier
application number: M012
Universal Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUSUniversal Distribution Center LLCb1d25572-da21-408d-aab3-3a0741dfff122023-11-16WarningsExact identifier
application number: M012
Daytime Cold and Flu Severe, Caseys 4googACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATEDLil' Drug Store Products, Inc.0334259d-587e-b2d5-e063-6394a90a3e562023-11-14WarningsExact identifier
application number: M012
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSato Pharmaceutical Co., Ltd.0b638db4-5ed3-4665-abcd-f95e677adbd82023-11-12WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc6c90b415-4c5f-49e5-beb6-4cf225797b212023-11-06WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc8b8582c0-8aef-482f-9738-2f1d4e325d642023-11-06WarningsExact identifier
application number: M012
Cold and Flu Severe Daytime/NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC27ade5f8-2003-4dc6-9244-42676791e1f82023-11-06WarningsExact identifier
application number: M012
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Incec2070df-8a8a-4cd1-8830-62655433fb3b2023-11-05WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION093eed84-79b1-7914-e063-6394a90a37af2023-11-03WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff68377-2273-6c6c-e053-2995a90a36b22023-11-03WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLC096bbcaa-fce1-0fc2-e063-6294a90ad5972023-11-03WarningsExact identifier
application number: M012
TopCare Nite Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCadc8edf5-ebbe-4d94-9018-aa0dbe1181122023-11-03WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83173-117-258317301172525 DOSE PACK in 1 BAG (83173-117-25) / 2.7 mg in 1 DOSE PACK25 dose pack2023-02-12NoNoCurrent