FDA.reportPublic FDA data

COUGH MEDICINE

Product NDC
76206-002
Requested package NDC
76206-002-01
11-digit product format
762060002
Labeler code
76206
Product ID
76206-002_a6d057b3-f01b-c377-e053-2995a90a41b0
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan
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
Active strength
30 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76206-00276206-002-01IInactivated by FDA2026-10-05

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 · 19 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05110d247fa046…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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76206-002-012022-01-28C16284748780-19855e2a2-4377-60a7-e053-dbdaa90a05bdDrug Facts
76206-002-012020-06-02C16284748780-19855e2a2-4377-60a7-e053-dbdaa90a05bdDrug Facts
76206-002-012019-11-27C16284748780-19855e2a2-4377-60a7-e053-dbdaa90a05bdDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76206-002-01COUGH MEDICINEsoothing relief6 in 1 BOXLIQUID63
76206-002-10COUGH MEDICINEsoothing relief10 mL in 1 BOTTLE, GLASSLIQUID103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH MEDICINE SOOTHING RELIEF (DEXTROMETHORPHAN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH MEDICINE SOOTHING RELIEF (DEXTROMETHORPHAN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
APRICOT KERNEL OILINACTIVE INGREDIENT54JB35T06ACOUGH MEDICINE SOOTHING RELIEF (DEXTROMETHORPHAN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
FRITILLARIA DELAVAYI BULBINACTIVE INGREDIENTAG6Q756AT7COUGH MEDICINE SOOTHING RELIEF (DEXTROMETHORPHAN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
HONEYINACTIVE INGREDIENTY9H1V576FHCOUGH MEDICINE SOOTHING RELIEF (DEXTROMETHORPHAN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH MEDICINE SOOTHING RELIEF (DEXTROMETHORPHAN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76206-002COUGH MEDICINE SOOTHING RELIEF (DEXTROMETHORPHAN) LIQUID [RFX PHARMACEUTICAL CO., LTD.]3Legacy NDC, 2 package rows20200530_0de33537-117c-4ed4-a029-5432ebdf02ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090496dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN0de33537-117c-4ed4-a029-5432ebdf02ea3
1090496dextromethorphan hydrobromide 3 MG/ML Oral SolutionSCD0de33537-117c-4ed4-a029-5432ebdf02ea3
1090496dextromethorphan hydrobromide 15 MG per 5 ML Oral SolutionSY0de33537-117c-4ed4-a029-5432ebdf02ea3
1090496dextromethorphan hydrobromide 30 MG per 10 ML Oral SolutionSY0de33537-117c-4ed4-a029-5432ebdf02ea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76206-002-01762060002016 BOTTLE, GLASS in 1 BOX (76206-002-01) > 10 mL in 1 BOTTLE, GLASS (76206-002-10) 2014-01-300000-00-00NoNoCurrent