Topcare Mucus Relief

Product NDC
36800-145
Requested package NDC
36800-145-01
11-digit product format
368000145
Labeler code
36800
Product ID
36800-145_2df8a96b-848e-4fc5-a467-e8bc2da74b84
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, guaifenesin, phenylephrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage36800-14536800-145-01DDiscontinued by firm2026-10-15

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 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…

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
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
GUAIFENESINACTIVE INGREDIENT495W7451VQTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
GUAIFENESINACTIVE MOIETY495W7451VQTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ETOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [TOPCO ASSOCIATES LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-145-013680001450110 BLISTER PACK in 1 CARTON (36800-145-01) > 2 TABLET, COATED in 1 BLISTER PACK10 blister pack2013-06-280000-00-00NoNoCurrent