CVS Chest Congestion Relief

Product NDC
10956-003
11-digit product format
109560003
Labeler code
10956
Product ID
10956-003_74179880-e043-40b7-ba3a-8a3e7a5cc557
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide / Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Reese Pharmaceutical Co
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-12-07
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/1; mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10956-003IInactivated by FDA2026-10-05
excluded packagepackage10956-00310956-003-01IInactivated by FDA2026-10-05
excluded packagepackage10956-00310956-003-01IInactivated by FDA2026-10-05
excluded packagepackage10956-00310956-003-01IInactivated 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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10956-003-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10956-003-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10956-003-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10956-003-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10956-003-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10956-003-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10956-003-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10956-003-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10956-003-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10956-003-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10956-003-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10956-003-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10956-003-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10956-003-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10956-003-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10956-003-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10956-003-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10956-003-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10956-003-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10956-003-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10956-003-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10956-003-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10956-003-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10956-003-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10956-003-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10956-003-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10956-003-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10956-003-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10956-003-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10956-003-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10956-003-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10956-003-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10956-003-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10956-003-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10956-003-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10956-003-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10956-003-018af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10956-003-018af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10956-003-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10956-003-01834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10956-003-01834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10956-003-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10956-003-011332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10956-003-011332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10956-003-011332a3947898…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
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
10956-003-012020-01-31C16284748780-19d75b9d0-f8d1-f424-e053-dadaa90a57ceDrug Facts CVS Congestion Relief DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10956-003-01CVS Chest Congestion ReliefDM1 in 1 CARTONTABLET11
10956-003-30CVS Chest Congestion ReliefDM30 in 1 BOTTLE, PLASTICTABLET301
10956-003-60CVS Chest Congestion ReliefDM60 in 1 BOTTLE, PLASTICTABLET601
10956-003-90CVS Chest Congestion ReliefDM90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10956-003-30EA - Each10956-00338174029-2114-4259-968f-b7f667eb127b12017-11-06
10956-003-60EA - Each10956-003a5896827-d945-4b1b-94b9-ce3ce80b86ee12017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
GuaifenesinACTIVE INGREDIENT495W7451VQCVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
GuaifenesinACTIVE MOIETY495W7451VQCVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
SILICON DIOXIDE, COLLOIDALINACTIVE INGREDIENTETJ7Z6XBU4CVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-003CVS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1Legacy NDC, 4 package rows20101007_19dfdf4d-4a58-4ffb-8d62-394fcaaa7298.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN19dfdf4d-4a58-4ffb-8d62-394fcaaa72981
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD19dfdf4d-4a58-4ffb-8d62-394fcaaa72981
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY19dfdf4d-4a58-4ffb-8d62-394fcaaa72981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10956-003-01109560003011 in 1 CARTONHistorical
10956-003-301095600033030 in 1 BOTTLE, PLASTICHistorical
10956-003-601095600036060 in 1 BOTTLE, PLASTICHistorical
10956-003-901095600039090 in 1 BOTTLE, PLASTICHistorical