Home NDC 36800-964 topcare flu and severe cold and cough
Product NDC 36800-964
11-digit product format 368000964
Labeler code 36800
Product ID 36800-964_502a8657-8fe5-40f6-827e-d7fd8471a222
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Topco Associates LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-09-10
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 36800-964-91 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 36800-964-91 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 36800-964-91 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 36800-964-91 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 36800-964-91 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 36800-964-91 cdf11ea48f46…ba0047e9e063…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 TOPCARE FLU AND SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TOPCO ASSOCIATES LLC] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-964-91 36800096491 6 POWDER, FOR SOLUTION in 1 CARTON (36800-964-91) 2012-09-10 0000-00-00 No No Current