Home NDC 54151-101 Ingenue
Product NDC 54151-101
11-digit product format 541510101
Labeler code 54151
Product ID 54151-101_78c157ec-598d-4916-9cf2-7e9619f26ca0
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Ingenue, LLC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-06-15
Marketing end 0000-00-00
Substance ZINC OXIDE
Active strength 15 mg/mL
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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 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 54151-101-26 Ingenue 50 mL in 1 TUBE CREAM 50 1 54151-101-26 Ingenue 1 in 1 BOX CREAM 1 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 ANNATTO INACTIVE INGREDIENT 6PQP1V1B6O INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 C13-14 ISOPARAFFIN INACTIVE INGREDIENT E4F12ROE70 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 CARROT INACTIVE INGREDIENT L56Z1JK48B INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 CHAMOMILE INACTIVE INGREDIENT FGL3685T2X INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 CUCUMBER INACTIVE INGREDIENT YY7C30VXJT INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 CYCLOMETHICONE INACTIVE INGREDIENT NMQ347994Z INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 EGG PHOSPHOLIPIDS INACTIVE INGREDIENT 1Z74184RGV INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 FERULIC ACID INACTIVE INGREDIENT AVM951ZWST INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 GLYCYRRHIZA GLABRA INACTIVE INGREDIENT 2788Z9758H INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 GLYCYRRHIZINATE DIPOTASSIUM INACTIVE INGREDIENT CA2Y0FE3FX INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 HYALURONATE SODIUM INACTIVE INGREDIENT YSE9PPT4TH INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 LAURETH-7 INACTIVE INGREDIENT Z95S6G8201 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 LENTINULA EDODES MYCELIUM INACTIVE INGREDIENT CU2S39TB8O INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 MACROCYSTIS PYRIFERA INACTIVE INGREDIENT K31S3OG5C4 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 PEA INACTIVE INGREDIENT W4X7H8GYFM INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 PHYLLANTHUS EMBLICA FRUIT INACTIVE INGREDIENT YLX4CW2576 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 POLYACRYLAMIDE (10000 MW) INACTIVE INGREDIENT E2KR9C9V2I INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 SODIUM DEHYDROACETATE INACTIVE INGREDIENT 8W46YN971G INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 SOYBEAN INACTIVE INGREDIENT L7HT8F1ZOD INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 STEARETH-21 INACTIVE INGREDIENT 53J3F32P58 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 SYNTHETIC WAX (1800 MW) INACTIVE INGREDIENT 248P1AUJ90 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 TETRAHEXYLDECYL ASCORBATE INACTIVE INGREDIENT 9LBV3F07AZ INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 TETRAHYDRODIFERULOYLMETHANE INACTIVE INGREDIENT 00U0645U03 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 WATERMELON INACTIVE INGREDIENT 231473QB6R INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54151-101 INGENUE (ZINC OXIDE) CREAM [INGENUE, LLC] 1 Legacy NDC, 2 package rows 20121207_018c7150-ac31-4376-a769-d35ea7456bcd.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 54151-101-26 54151010126 50 mL in 1 TUBE 50 ml Historical