Home NDC 0904-7760 Clear Anti Itch
Product NDC 0904-7760
11-digit product format 009047760
Labeler code 0904
Product ID 0904-7760_6f2160d5-e176-47c9-8f6e-3bd026259755
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine HCl, Zinc acetate
Dosage form LOTION
Route TOPICAL
Labeler Major Pharmaceuticals
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 1995-04-18
Marketing end 0000-00-00
Substance PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength 10 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2022-12-31
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 · 24 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 0904-7760-21 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 0904-7760-21 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 0904-7760-21 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 0904-7760-21 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 0904-7760-21 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 0904-7760-21 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0904-7760-21 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0904-7760-21 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0904-7760-21 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0904-7760-21 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0904-7760-21 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0904-7760-21 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 PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 ZINC ACETATE ACTIVE INGREDIENT FM5526K07A CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 CAMPHOR (NATURAL) INACTIVE INGREDIENT N20HL7Q941 CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 HYDROXYPROLINE INACTIVE INGREDIENT RMB44WO89X CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 LAVENDER OIL INACTIVE INGREDIENT ZBP1YXW0H8 CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 POLYSORBATE 40 INACTIVE INGREDIENT STI11B5A2X CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 ROSEMARY OIL INACTIVE INGREDIENT 8LGU7VM393 CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [MAJOR PHARMACEUTICALS] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-7760-21 00904776021 177 mL in 1 BOTTLE, PLASTIC (0904-7760-21) 177 ml 1995-04-18 0000-00-00 No No Current