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

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 Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui199099, 1494206

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