FDA.reportPublic FDA data

Sheer Glow

Product NDC
70809-1910
Requested package NDC
70809-1910-2
11-digit product format
708091910
Labeler code
70809
Product ID
70809-1910_eaec7dca-cdd7-c4d3-e053-2995a90a33b7
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
USRX LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2001-07-19
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
12 mg/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70809-191070809-1910-2IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70809-1910-12023-10-2070809-1910 Sheer Glow
70809-1910-22023-10-2070809-1910 Sheer Glow
70809-1910-12023-07-2870809-1910 Sheer Glow
70809-1910-22023-07-2870809-1910 Sheer Glow

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70809-1910-1Sheer Glow1 in 1 BOXCREAM15
70809-1910-1Sheer Glow66.5 mL in 1 TUBECREAM66.55
70809-1910-2Sheer Glow15 mL in 1 TUBECREAM155
70809-1910-2Sheer Glow1 in 1 BOXCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70809-1910SHEER GLOW (ZINC OXIDE) CREAM [USRX LLC]5Legacy NDC, 4 package rows20241004_c77f6973-04a7-260d-e053-2a95a90ab48a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70809-1910-2708091910021 TUBE in 1 BOX (70809-1910-2) > 15 mL in 1 TUBE1 tube2021-06-010000-00-00NoNoCurrent