Home NDC 58875-101 Hard Candy Correction Creme
Product NDC 58875-101
11-digit product format 588750101
Labeler code 58875
Product ID 58875-101_e0dd7b3f-fd21-4e0d-94a2-8603b38c9442
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate
Dosage form CREAM
Route TOPICAL
Labeler Xtreme Color Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2013-06-12
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE
Active strength 3 g/42.5g; g/42.5g
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 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 58875-101-01 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 58875-101-01 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 58875-101-01 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 58875-101-01 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 58875-101-01 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 58875-101-01 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 58875-101-01 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 58875-101-01 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 58875-101-01 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 58875-101-01 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 58875-101-01 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 58875-101-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58875-101-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58875-101-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58875-101-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 58875-101-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 58875-101-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 58875-101-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58875-101-01 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58875-101-01 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58875-101-01 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58875-101-01 110d247fa046…a55b01930146…
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58875-101-01 Hard Candy Correction Creme 42.5 g in 1 TUBE CREAM 42.5 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 CARMINIC ACID INACTIVE INGREDIENT CID8Z8N95N HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) INACTIVE INGREDIENT 035JKJ76MT HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 CHROMIC OXIDE INACTIVE INGREDIENT X5Z09SU859 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 DISTEARDIMONIUM HECTORITE INACTIVE INGREDIENT X687XDK09L HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 FERRIC FERROCYANIDE INACTIVE INGREDIENT TLE294X33A HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 HYDROGENATED POLYDECENE (550 MW) INACTIVE INGREDIENT U333RI6EB7 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 ISODODECANE INACTIVE INGREDIENT A8289P68Y2 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 MICA INACTIVE INGREDIENT V8A1AW0880 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) INACTIVE INGREDIENT 59Z907ZB69 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 PROPYLENE CARBONATE INACTIVE INGREDIENT 8D08K3S51E HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 SILICA DIMETHYL SILYLATE INACTIVE INGREDIENT EU2PSP0G0W HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 SODIUM STEAROYL LACTYLATE INACTIVE INGREDIENT IN99IT31LN HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 STEARETH-2 INACTIVE INGREDIENT V56DFE46J5 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 TRIBEHENIN INACTIVE INGREDIENT 8OC9U7TQZ0 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58875-101 HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.] 1 Legacy NDC, 1 package rows 20130917_a3d06086-2c4c-44d4-a242-f452d163cb9f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 58875-101-01 58875010101 42.5 g in 1 TUBE 42.5 g Historical