FDA.reportPublic FDA data

Dr Smiths Diaper Rash

Product NDC
0178-0345
11-digit product format
001780345
Labeler code
0178
Product ID
0178-0345_0a6b5d7c-e58c-a07a-392a-3bac2a390602
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
Mission Pharmacal Company
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-04-07
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0178-0345DDiscontinued by firm2026-08-17
excluded packagepackage0178-03450178-0345-03DDiscontinued by firm2026-08-17

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 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0178-0345-03DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0178-0345-03DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0178-0345-03DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0178-0345-03DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0178-0345-03DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0178-0345-03DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0178-0345-03DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0178-0345-03DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0178-0345-03DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0178-0345-03DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0178-0345-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0178-0345-03DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0178-0345-03IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0178-0345-03IInactivated by FDA9bebd1f3094a…5416666fcb17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0178-0345-032021-12-23C16284748780-19d75b9d0-73ea-f424-e053-dadaa90a57ceDrug Facts
0178-0345-032020-01-31C16284748780-19d75b9d0-73ea-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0345-03GM - Gram0178-0345d78c8703-97cd-4ace-990d-625be369855212014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
1,3,3,3-TETRAFLUOROPROPENE, (1E)-INACTIVE INGREDIENT5I2481UOO8DR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
C12-15 ALKYL LACTATEINACTIVE INGREDIENTGC844VRD7EDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
PEG-30 DIPOLYHYDROXYSTEARATEINACTIVE INGREDIENT9713Q0S7FODR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7DR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
SODIUM ACRYLOYLDIMETHYLTAURATEINACTIVE INGREDIENT2T9Q6EKI0GDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56DR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
SQUALANEINACTIVE INGREDIENTGW89575KF9DR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
THYMOL IODIDEINACTIVE INGREDIENTA51HJM3XSUDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RDR SMITHS DIAPER RASH (ZINC OXIDE) SPRAY [MISSION PHARMACAL COMPANY]2