Home NDC 35418-111 Histenol Forte II
Product NDC 35418-111
11-digit product format 354180111
Labeler code 35418
Product ID 35418-111_f19b94fe-7bea-319d-e053-2a95a90a74f0
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine HCl, Acetaminophen, Guaifenesin
Dosage form TABLET
Route ORAL
Labeler Zee Medical Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-06-12
Marketing end 2023-04-01
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
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 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 35418-111-67 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 35418-111-67 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 35418-111-67 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 35418-111-67 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 35418-111-67 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 35418-111-67 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 35418-111-67 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 35418-111-67 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 35418-111-67 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 35418-111-67 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 35418-111-67 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 35418-111-67 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 35418-111-67 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 35418-111-67 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 35418-111-67 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 35418-111-67 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35418-111-67 35418011167 125 CARTON in 1 CARTON (35418-111-67) > 50 PACKET in 1 CARTON (35418-111-68) > 2 TABLET in 1 PACKET (35418-111-02) 125 carton 2012-06-12 2023-04-01 No No Current