Home NDC 11086-021-01 TRIPLE
Product NDC 11086-021
Requested package NDC 11086-021-01
11-digit product format 110860021
Labeler code 11086
Product ID 11086-021_f2143810-4127-0f93-e053-2a95a90a053a
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form PASTE
Route TOPICAL
Labeler Summers Laboratories Inc
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-10-30
Marketing end 0000-00-00
Substance ZINC OXIDE
Active strength 13 g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2024-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11086-021-01 TRIPLEMEDICATED FOR DIAPER RASH 56.7 g in 1 TUBE PASTE 56.7 12 11086-021-02 TRIPLEMEDICATED FOR DIAPER RASH 454 g in 1 JAR PASTE 454 12 11086-021-03 TRIPLEMEDICATED FOR DIAPER RASH 240 g in 1 PACKAGE PASTE 240 12 11086-021-05 TRIPLEMEDICATED FOR DIAPER RASH 284 g in 1 PACKAGE PASTE 284 12 11086-021-06 TRIPLEMEDICATED FOR DIAPER RASH 100 g in 1 PACKAGE PASTE 100 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11086-021 TRIPLE MEDICATED FOR DIAPER RASH (ZINC OXIDE) PASTE [SUMMERS LABORATORIES INC] 12 Legacy NDC, 5 package rows 20231012_f9fd9395-48bc-43be-a3d9-ec7fcad339a9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11086-021-01 11086002101 56.7 g in 1 TUBE (11086-021-01) 56.7 g 2013-10-30 0000-00-00 No No Current