Home NDC 0573-2952-10 PRIMATENE
Product NDC 0573-2952
Requested package NDC 0573-2952-10
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT NLJ6390P1Z PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4 EPHEDRINE ACTIVE MOIETY GN83C131XS PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4 GUAIFENESIN ACTIVE MOIETY 495W7451VQ PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PRIMATENE (EPHEDRINE HCL, GUAIFENESIN ) TABLET [PFIZER CONSUMER HEALTHCARE] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0573-2952-10 00573295210 2 BLISTER PACK in 1 CARTON (0573-2952-10) > 12 TABLET in 1 BLISTER PACK 2 blister pack 2004-01-06 2023-06-30 No No Current