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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0178-0330	0178-0330-02	D	Discontinued by firm		2026-10-16
excluded package	package	0178-0330	0178-0330-08	D	Discontinued by firm		2026-10-16

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 date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0178-0330-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0178-0330-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0178-0330-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0178-0330-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0178-0330-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0178-0330-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0178-0330-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0178-0330-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0178-0330-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0178-0330-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0178-0330-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0178-0330-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0178-0330-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0178-0330-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0178-0330-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0178-0330-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0178-0330-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0178-0330-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0178-0330-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0178-0330-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0178-0330-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0178-0330-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0178-0330-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0178-0330-02	`557ba5c1ecfa…`	`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
Ingredient	Strength
ZINC OXIDE	100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
7705b182-acf7-4195-9996-7d9fcdfbf055	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0178-0330-02	2021-12-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-02	2021-12-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-03	2021-12-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-03	2021-12-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-08	2021-12-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-08	2021-12-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-02	2021-07-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-02	2021-07-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-03	2021-07-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-03	2021-07-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-08	2021-07-23	Dr. Smith’s Diaper Rash Ointment
0178-0330-08	2021-07-23	Dr. Smith’s Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0178-0330-02	DR SMITHS DIAPER	56.7 g in 1 JAR	OINTMENT	56.7	10
0178-0330-03	DR SMITHS DIAPER	85 g in 1 TUBE	OINTMENT	85	10
0178-0330-08	DR SMITHS DIAPER	226.8 g in 1 JAR	OINTMENT	226.8	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0178-0330-02	GM - Gram	0178-0330	9b4b8d22-b5ed-4887-862f-f7029646fef2	1	2012-07-24
0178-0330-03	GM - Gram	0178-0330	e6169e17-e9eb-4418-abee-ebec10406b35	1	2012-07-24
0178-0330-08	GM - Gram	0178-0330	ae3c2f28-9be9-4662-912c-f860a3c081c2	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	6
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	6
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	6
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	6
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	6
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	6
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	6
THYMOL IODIDE	INACTIVE INGREDIENT	A51HJM3XSU	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	6
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0178-0330	DR SMITHS DIAPER (ZINC OXIDE) OINTMENT [MISSION PHARMACAL]	9	Current NDC, Legacy NDC, 3 package rows	20231006_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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EELHOE Cuticle Pusher Pen	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	52c7f956-a2a1-ae1d-e063-6294a90ab3c2	2026-05-27	Warnings	Exact identifier application number: M016
Dermoia Eczema Relief Colloidal Oatmeal	OATMEAL	Treasurewise LLC	1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a	2026-05-27	Warnings	Exact identifier application number: M016
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Wal-Mart Stores, Inc.	61e76e2a-fc46-7a64-e053-2991aa0a56a8	2026-05-26	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Wal-Mart Stores, Inc.	61929c97-bd6b-0d7c-e053-2991aa0aa571	2026-05-26	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Pharma Nobis, LLC	fbcfa541-beda-06de-e053-6294a90a9298	2026-05-26	Warnings	Exact identifier application number: M016
Humco Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Humco holding Group, Inc.	f7dcd959-fb98-43bb-8dd3-a662bf8a053c	2026-05-26	Warnings	Exact identifier application number: M016
Advanced Healing	PETROLATUM	CVS Pharamacy, Inc	0bd3380e-2284-44a7-b2ef-68c9909627fd	2026-05-26	Warnings, Adverse reactions	Exact identifier application number: M016
CeraVe Developed with Dermatologists Healing Lip Balm	PETROLATUM	L'Oreal USA Products Inc	21dc8842-0672-4d46-bcea-b8e3d54c48bf	2026-05-20	Warnings	Exact identifier application number: M016
AFTER CARE	DIMETHICONE	Merz North America	c19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae	2026-05-20	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	63b551fc-7d16-c099-e053-2a91aa0a5f2c	2026-05-18	Warnings	Exact identifier application number: M016
ADVANCED SILICONE SCAR	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	51ffdc45-5acf-ae20-e063-6294a90a55e8	2026-05-17	Warnings	Exact identifier application number: M016
LCFateLC Nail Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	51ea23f4-0a23-4ae1-e063-6394a90aa051	2026-05-16	Warnings	Exact identifier application number: M016
Radlive Active Defense Nano-Silver Cream	COLLOIDAL OATMEAL	SilverCeuticals	51e23135-008d-9db5-e063-6294a90a7d61	2026-05-15	Warnings	Exact identifier application number: M016
Cerave Developed with Dermatologists Healing	PETROLATUM	LOreal USA Products Inc	de44ac01-ba17-4f97-ac12-9ea348013bde	2026-05-14	Warnings	Exact identifier application number: M016
Triple 3x Max Diaper Rash	ZINC OXIDE	Advantice Health, LLC	e554046b-cd0a-4a6e-8f24-2e610c697432	2026-05-14	Warnings	Exact identifier application number: M016
Eczema Therapy	COLLOIDAL OATMEAL	SilverCeuticals	3a26a35e-a098-0e22-e063-6294a90a96b9	2026-05-13	Warnings	Exact identifier application number: M016
Nail- Pflaster	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	519681bc-6312-f627-e063-6394a90a2845	2026-05-11	Warnings	Exact identifier application number: M016
Hydrating	PETROLATUM	Aldermed Inc.	4aa6a354-e487-4b65-e063-6394a90abbf0	2026-05-09	Warnings	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Aldermed Inc.	4aa79292-dc91-b538-e063-6294a90ac3f0	2026-05-09	Warnings	Exact identifier application number: M016
XIMONTH Nail Fungus Care Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	514a998d-aa2a-46b6-e063-6294a90a6c22	2026-05-08	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1494206	Dr. Smith's Diaper Ointment 10 % Topical Ointment	PSN	7705b182-acf7-4195-9996-7d9fcdfbf055	10
199099	zinc oxide 10 % Topical Ointment	PSN	7705b182-acf7-4195-9996-7d9fcdfbf055	10
1494206	zinc oxide 0.1 MG/MG Topical Ointment [Dr. Smith's Diaper Rash]	SBD	7705b182-acf7-4195-9996-7d9fcdfbf055	10
199099	zinc oxide 0.1 MG/MG Topical Ointment	SCD	7705b182-acf7-4195-9996-7d9fcdfbf055	10
1494206	Dr. Smith's Adult Barrier 10 % Topical Ointment	SY	7705b182-acf7-4195-9996-7d9fcdfbf055	10
1494206	Dr. Smith's Diaper Ointment 10 % Topical Ointment	SY	7705b182-acf7-4195-9996-7d9fcdfbf055	10
1494206	Dr. Smith's Diaper Rash 0.1 MG/MG Topical Ointment	SY	7705b182-acf7-4195-9996-7d9fcdfbf055	10
199099	zinc oxide 10 % Topical Ointment	SY	7705b182-acf7-4195-9996-7d9fcdfbf055	10
199099	ZNO 0.1 MG/MG Topical Ointment	SY	7705b182-acf7-4195-9996-7d9fcdfbf055	10
1494206	ZNO 0.1 MG/MG Topical Ointment [Dr. Smith's Diaper Rash]	SY	7705b182-acf7-4195-9996-7d9fcdfbf055	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0178-0330-02	00178033002	56.7 g in 1 JAR (0178-0330-02)	56.7 g	2010-03-01	0000-00-00	No	No	Current
0178-0330-03	00178033003	85 g in 1 TUBE (0178-0330-03)	85 g	2023-10-05	0000-00-00	No	No	Current
0178-0330-08	00178033008	226.8 g in 1 JAR (0178-0330-08)	226.8 g	2010-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dr. Smith’s Diaper Rash Ointment	Mission Pharmacal \| Mission Pharmacal Company	2026-01-08	HUMAN OTC DRUG LABEL	10