Home NDC 51514-0235 Babyganics
Product NDC 51514-0235
11-digit product format 515140235
Labeler code 51514
Product ID 51514-0235_87630dc9-73ce-4ec1-bb04-d08159ec6aba
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, and Zinc
Dosage form SPRAY
Route TOPICAL
Labeler Autumn Harp, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-02-23
Marketing end 0000-00-00
Substance ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength 112 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2019-12-31
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 · 40 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 2025-08-27 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 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 51514-0235-1 9bebd1f3094a…5416666fcb17…
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 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 2 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 2 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 2 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 2 OCTISALATE ACTIVE MOIETY 4X49Y0596W BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 2 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51514-0235 BABYGANICS SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC) SPRAY [AUTUMN HARP, INC.] 3 Legacy NDC 20181212_f40a8efa-2cbe-4e99-aba3-66eb59b70332.zip