DR SMITHS DIAPER

Product NDC
0178-0330
11-digit product format
001780330
Labeler code
0178
Product ID
0178-0330_47e710bf-d93c-068a-e063-6294a90a584b
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Mission Pharmacal
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-03-01
Substance
ZINC OXIDE
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage0178-03300178-0330-02DDiscontinued by firm2026-10-12
excluded packagepackage0178-03300178-0330-08DDiscontinued by firm2026-10-12

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050178-0330-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050178-0330-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260178-0330-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260178-0330-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310178-0330-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310178-0330-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280178-0330-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280178-0330-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210178-0330-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210178-0330-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100178-0330-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100178-0330-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310178-0330-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310178-0330-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200178-0330-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200178-0330-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100178-0330-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100178-0330-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080178-0330-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080178-0330-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030178-0330-08367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030178-0330-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090178-0330-08557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090178-0330-02557ba5c1ecfa…9c80585c8c6e…

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
DR SMITHS DIAPER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199099Internal RxNorm lookup
1494206Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7705b182-acf7-4195-9996-7d9fcdfbf055Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0330-02DR SMITHS DIAPER56.7 g in 1 JAROINTMENT56.710
0178-0330-03DR SMITHS DIAPER85 g in 1 TUBEOINTMENT8510
0178-0330-08DR SMITHS DIAPER226.8 g in 1 JAROINTMENT226.810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0330-02GM - Gram0178-03309b4b8d22-b5ed-4887-862f-f7029646fef212012-07-24
0178-0330-03GM - Gram0178-0330e6169e17-e9eb-4418-abee-ebec10406b3512012-07-24
0178-0330-08GM - Gram0178-0330ae3c2f28-9be9-4662-912c-f860a3c081c212015-02-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0330DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]9Current NDC, Legacy NDC, 3 package rows20231006_7705b182-acf7-4195-9996-7d9fcdfbf055.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 2 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
application number: M016
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
application number: M016
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELUnited Natural Foods, Inc. dba UNFId2d1bd9e-7025-4151-95f2-a2f521dc2be82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-08-27WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
application number: M016
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsExact identifier
application number: M016
Serawise Eczema ReliefOATMEALDrAnaMaria. Com LLCf0681436-d140-4e02-afe4-5b16de07afcd2026-08-26WarningsExact identifier
application number: M016
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
application number: M016
Growth TreatmentGLYCERINShantou Ouhoe Technology Co., Ltd.59fe12eb-574f-a199-e063-6394a90abd062026-08-26WarningsExact identifier
application number: M016
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELYour Military Exchanges4079fd56-55f3-4e69-93e0-7590c07fb7942026-08-25Warnings, Adverse reactionsExact identifier
application number: M016
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
application number: M016
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494206Dr. Smith's Diaper Ointment 10 % Topical OintmentPSN7705b182-acf7-4195-9996-7d9fcdfbf05510
199099zinc oxide 10 % Topical OintmentPSN7705b182-acf7-4195-9996-7d9fcdfbf05510
1494206zinc oxide 0.1 MG/MG Topical Ointment [Dr. Smith's Diaper Rash]SBD7705b182-acf7-4195-9996-7d9fcdfbf05510
199099zinc oxide 0.1 MG/MG Topical OintmentSCD7705b182-acf7-4195-9996-7d9fcdfbf05510
1494206Dr. Smith's Adult Barrier 10 % Topical OintmentSY7705b182-acf7-4195-9996-7d9fcdfbf05510
1494206Dr. Smith's Diaper Ointment 10 % Topical OintmentSY7705b182-acf7-4195-9996-7d9fcdfbf05510
1494206Dr. Smith's Diaper Rash 0.1 MG/MG Topical OintmentSY7705b182-acf7-4195-9996-7d9fcdfbf05510
199099zinc oxide 10 % Topical OintmentSY7705b182-acf7-4195-9996-7d9fcdfbf05510
199099ZNO 0.1 MG/MG Topical OintmentSY7705b182-acf7-4195-9996-7d9fcdfbf05510
1494206ZNO 0.1 MG/MG Topical Ointment [Dr. Smith's Diaper Rash]SY7705b182-acf7-4195-9996-7d9fcdfbf05510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0330-020017803300256.7 g in 1 JAR (0178-0330-02) 56.7 g2010-03-010000-00-00NoNoCurrent
0178-0330-030017803300385 g in 1 TUBE (0178-0330-03) 85 g2023-10-050000-00-00NoNoCurrent
0178-0330-0800178033008226.8 g in 1 JAR (0178-0330-08) 226.8 g2010-03-010000-00-00NoNoCurrent