Home NDC 78518-007 Cream
Product NDC 78518-007
11-digit product format 785180007
Labeler code 78518
Product ID 78518-007_46e05ccb-82a8-f692-e063-6294a90a079a
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler MONAT GLOBAL CORP
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-12
Substance ZINC OXIDE
Active strength 18.8 mg/100mg
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 18 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 78518-007-01 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 78518-007-01 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 78518-007-01 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 78518-007-01 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 78518-007-01 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 78518-007-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 78518-007-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 78518-007-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 78518-007-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 18.8 mg/100mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 78518-007-01 Cream 1 in 1 CARTON CREAM 1 3 78518-007-01 Cream 35 mg in 1 TUBE CREAM 35 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78518-007 CREAM (ZINC OXIDE) CREAM [MONAT GLOBAL CORP] 2 Current NDC, Legacy NDC, 2 package rows 20230812_e9231470-9292-0e70-e053-2a95a90a767a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 119 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anti Aging Daily Protection ZINC OXIDE LEVERRIER, KAMILA 35465f21-8bcd-6e44-e063-6294a90a8e5f 2025-12-15 Exact identifier application number: M020 Anti Aging Daily Protection ZINC OXIDE LEVERRIER, KAMILA 3546d369-3435-b56a-e063-6294a90a0843 2025-12-15 Exact identifier application number: M020 Tinted Facial Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HELTON SKIN & LASER INSTITUTE 35a97770-2db9-99aa-e063-6294a90a459a 2025-12-15 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE HELTON SKIN & LASER INSTITUTE 35a9d07d-70e5-5eed-e063-6394a90aebaf 2025-12-15 Exact identifier application number: M020 Non-Tinted Sports Stick TITANIUM DIOXIDE, ZINC OXIDE HELTON SKIN & LASER INSTITUTE 35aa833a-19a1-99e9-e063-6394a90a840f 2025-12-15 Exact identifier application number: M020 Tinted Facial Primer TITANIUM DIOXIDE, ZINC OXIDE BEE NATURALS 36c3352e-fa51-19ad-e063-6394a90a591b 2025-12-15 Exact identifier application number: M020 Luminous Tinted Moisturizing ZINC OXIDE SKIN BOSS L.L.C. 35a8ae26-82eb-e4ca-e063-6394a90a0022 2025-12-15 Exact identifier application number: M020 Restore Tinted Moisturizing ZINC OXIDE SKIN BOSS L.L.C. 35a8e92e-ced2-fdcd-e063-6294a90acedc 2025-12-15 Exact identifier application number: M020 Velvet Tinted Moisturizing Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SKIN BOSS L.L.C. 35a871dc-a707-9963-e063-6294a90a4396 2025-12-15 Exact identifier application number: M020 Velvet NT Moisturizing Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SKIN BOSS L.L.C. 35a8508d-7069-c2d6-e063-6394a90a6219 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen NT ZINC OXIDE SKINPLUSBYOROYO LLC 35a94d6f-9b1c-1b26-e063-6394a90abe65 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen NT ZINC OXIDE SKINPLUSBYOROYO LLC 35a9a6ed-c446-c90c-e063-6294a90aaa74 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen Tinted ZINC OXIDE SKINPLUSBYOROYO LLC 35a9ecd7-b416-0aab-e063-6294a90a323d 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer NT TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 3596fe93-836b-4f8e-e063-6294a90a674a 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 359723bb-6152-9566-e063-6294a90a59e0 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen Tinted ZINC OXIDE SKINPLUSBYOROYO LLC 35aa194a-9a2e-2b5f-e063-6294a90a9877 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer NT TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 3596cd73-0811-32bc-e063-6394a90ad132 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 359782d7-6601-7d96-e063-6394a90af9dc 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY RIKI LLC 37f1b692-0b80-0536-e063-6294a90ae863 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY RIKI LLC 387d5194-bc12-68c1-e063-6394a90ab152 2025-12-15 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 78518-007-01 78518000701 1 TUBE in 1 CARTON (78518-007-01) / 35 mg in 1 TUBE 1 tube 2022-09-12 0000-00-00 No No Current