COUGH BE GONE

Product NDC
76206-001
11-digit product format
762060001
Labeler code
76206
Product ID
76206-001_a6cf8d75-ab8f-4044-e053-2a95a90a02e1
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
RFX Pharmaceutical Co., Ltd.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-01-30
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/10mL; mg/10mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76206-001IInactivated by FDA2026-10-15
excluded packagepackage76206-00176206-001-01IInactivated by FDA2026-10-15

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76206-001-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76206-001-01IInactivated 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 packagepackage76206-001-01IInactivated 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 packagepackage76206-001-01IInactivated 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 packagepackage76206-001-01IInactivated 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 packagepackage76206-001-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76206-001-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76206-001-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76206-001-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76206-001-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76206-001-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76206-001-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76206-001-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76206-001-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76206-001-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76206-001-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76206-001-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76206-001-01IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76206-001-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
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
76206-001-012022-01-28C16284748780-19d75b9d0-d2f7-f424-e053-dadaa90a57ceDrug Facts
76206-001-012020-03-03C16284748780-19d75b9d0-d2f7-f424-e053-dadaa90a57ceDrug Facts
76206-001-012020-01-31C16284748780-19d75b9d0-d2f7-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76206-001-01COUGH BE GONE6 in 1 BOXLIQUID64
76206-001-10COUGH BE GONE10 mL in 1 BOTTLE, GLASSLIQUID104

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCOUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
GUAIFENESINACTIVE MOIETY495W7451VQCOUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
ERIOBOTRYA JAPONICA LEAFINACTIVE INGREDIENTZ02066SV11COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
GINGERINACTIVE INGREDIENTC5529G5JPQCOUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
HONEYINACTIVE INGREDIENTY9H1V576FHCOUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
LICORICEINACTIVE INGREDIENT61ZBX54883COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ACOUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76206-001COUGH BE GONE (DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]4Legacy NDC, 2 package rows20200530_89a5588f-a6a6-40dd-b96f-79bd3ea9e31f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN89a5588f-a6a6-40dd-b96f-79bd3ea9e31f4
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD89a5588f-a6a6-40dd-b96f-79bd3ea9e31f4
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY89a5588f-a6a6-40dd-b96f-79bd3ea9e31f4
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY89a5588f-a6a6-40dd-b96f-79bd3ea9e31f4
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY89a5588f-a6a6-40dd-b96f-79bd3ea9e31f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76206-001-01762060001016 BOTTLE, GLASS in 1 BOX (76206-001-01) > 10 mL in 1 BOTTLE, GLASS (76206-001-10) 2014-01-300000-00-00NoNoCurrent
76206-001-107620600011010 mL in 1 BOTTLE, GLASS10 mlHistorical