Home NDC 69264-014 Callus Removal Foot Pack
Product NDC 69264-014
11-digit product format 692640014
Labeler code 69264
Product ID 69264-014_4a8a9ec2-6fc1-4881-8a5b-a4f229933cfc
Type HUMAN OTC DRUG
Nonproprietary name Salicylic acid 0.19%
Dosage form PATCH
Route TOPICAL
Labeler POLAROISIN INTERNATIONAL CO., LTD.
Application part358B
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-10-16
Marketing end 0000-00-00
Substance SALICYLIC ACID
Active strength 0 mg/1
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69264-014-25 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69264-014-25 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69264-014-25 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69264-014-25 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69264-014-25 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69264-014-25 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69264-014-25 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69264-014-25 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69264-014-25 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69264-014-25 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69264-014-25 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69264-014-25 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69264-014-25 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69264-014-25 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69264-014-25 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…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 69264-014-25 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 69264-014-25 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 69264-014-25 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 69264-014-25 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 69264-014-25 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 69264-014-25 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 69264-014-25 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69264-014-25 Callus Removal Foot Pack 2 in 1 BAG PATCH 2 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SALICYLIC ACID ACTIVE INGREDIENT O414PZ4LPZ CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 SALICYLIC ACID ACTIVE MOIETY O414PZ4LPZ CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 COLLAGEN ALPHA-1(III) (HUMAN) INACTIVE INGREDIENT 5D8UAE62VB CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 CUCUMBER INACTIVE INGREDIENT YY7C30VXJT CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 GLYCOLIC ACID INACTIVE INGREDIENT 0WT12SX38S CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 GLYCYRRHIZINATE DIPOTASSIUM INACTIVE INGREDIENT CA2Y0FE3FX CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 HYALURONATE SODIUM INACTIVE INGREDIENT YSE9PPT4TH CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 MANDELIC ACID INACTIVE INGREDIENT NH496X0UJX CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 METHYL GLUCETH-20 INACTIVE INGREDIENT J3QD0LD11P CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 SODIUM LACTATE INACTIVE INGREDIENT TU7HW0W0QT CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 SODIUM PYRROLIDONE CARBOXYLATE INACTIVE INGREDIENT 469OTG57A2 CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 TREHALOSE INACTIVE INGREDIENT B8WCK70T7I CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 UREA INACTIVE INGREDIENT 8W8T17847W CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69264-014 CALLUS REMOVAL FOOT PACK (SALICYLIC ACID 0.19%) PATCH [POLAROISIN INTERNATIONAL CO., LTD.] 1 Legacy NDC, 1 package rows 20141112_8bd794d6-399a-4b11-8f65-9b620099f913.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 69264-014-25 69264001425 2 in 1 BAG Historical