FDA.reportPublic FDA data

PRIMATENE

Product NDC
0573-2952
11-digit product format
005732952
Labeler code
0573
Product ID
0573-2952_c9baccdd-f72e-4461-b87f-bb220754610b
Type
HUMAN OTC DRUG
Nonproprietary name
ephedrine HCl, guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2004-01-06
Marketing end
2023-06-30
Substance
EPHEDRINE HYDROCHLORIDE; GUAIFENESIN
Active strength
13 mg/1; mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0573-2952DDiscontinued by firm2026-10-05
excluded packagepackage0573-29520573-2952-10DDiscontinued by firm2026-10-05
excluded packagepackage0573-29520573-2952-20DDiscontinued by firm2026-10-05

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 · 36 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 packagepackage0573-2952-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0573-2952-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0573-2952-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0573-2952-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0573-2952-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0573-2952-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0573-2952-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0573-2952-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0573-2952-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0573-2952-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0573-2952-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0573-2952-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0573-2952-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0573-2952-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0573-2952-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0573-2952-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0573-2952-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0573-2952-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0573-2952-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0573-2952-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0573-2952-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0573-2952-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0573-2952-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0573-2952-20557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2952-10EA - Each0573-295219f78a45-4bf0-4026-82f8-e9b60d0d5c8b12012-07-24
0573-2952-20EA - Each0573-29527875be38-0c5c-46a2-bae9-ea83eb60880112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPHEDRINE HYDROCHLORIDEACTIVE INGREDIENTNLJ6390P1ZPRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4
GUAIFENESINACTIVE INGREDIENT495W7451VQPRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4
EPHEDRINEACTIVE MOIETYGN83C131XSPRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4
GUAIFENESINACTIVE MOIETY495W7451VQPRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EPRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-2952-10005732952102 BLISTER PACK in 1 CARTON (0573-2952-10) > 12 TABLET in 1 BLISTER PACK2 blister pack2004-01-062023-06-30NoNoCurrent
0573-2952-20005732952205 BLISTER PACK in 1 CARTON (0573-2952-20) > 12 TABLET in 1 BLISTER PACK5 blister pack2004-01-062023-06-30NoNoCurrent