Sinus and Allergy

Product NDC
36800-810
11-digit product format
368000810
Labeler code
36800
Product ID
36800-810_b59c6a11-9d98-46eb-b45a-0a5c03605efe
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-05-30
Marketing end
2020-12-30
Substance
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-810DDiscontinued by firm2026-10-05
excluded packagepackage36800-81036800-810-62DDiscontinued 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 · 24 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 packagepackage36800-810-62d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-810-62f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-810-622ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-810-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-810-62cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-810-62cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-810-62302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-810-62ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-810-620efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-810-62ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-810-62367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-810-62557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZSINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965USINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BSINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]1