FDA.reportPublic FDA data

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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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 firm2026-07-31
excluded packagepackage0178-03300178-0330-08DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nail Fungus Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-07-28WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
application number: M016
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
application number: M016

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0178-0330-022021-12-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-022021-12-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-032021-12-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-032021-12-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-082021-12-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-082021-12-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-022021-07-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-022021-07-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-032021-07-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-032021-07-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-082021-07-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment
0178-0330-082021-07-23C16284748780-1c7ccaba7-243c-fd44-e053-dadaa90aa01bDr. Smith’s Diaper Rash Ointment

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]6
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]6
LANOLININACTIVE INGREDIENT7EV65EAW6HDR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]6
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPDR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]6
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EDR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]6
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEDR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]6
THYMOL IODIDEINACTIVE INGREDIENTA51HJM3XSUDR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]6
WATERINACTIVE INGREDIENT059QF0KO0RDR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]6
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VDR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]6

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

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