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		2026-10-15
excluded package	package	0178-0330	0178-0330-08	D	Discontinued by firm		2026-10-15

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 7 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sosnowskis Magic Healing Multi action	CAMPHOR AND COLLOIDAL OATMEAL	Herstat (USA) Inc.	38cd8f11-7264-a004-e063-6294a90a3a1b	2026-07-03	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Publix Super Markets, Inc.	c94b5574-3fd7-48a8-94ef-db5d7184fa10	2026-07-02	Warnings, Adverse reactions	Exact identifier application number: M016
Drs. Pharmacy Baby Healing	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	55a6981c-1b32-f448-e063-6294a90ac6d8	2026-07-02	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	558d239e-b0cf-c145-e063-6294a90a8a8b	2026-07-01	Warnings	Exact identifier application number: M016
DIMETHICONE SKIN PROTECTANT	DIMETHICONE	VIVE HEALTH LLC	5591a321-4831-1844-e063-6394a90a12d1	2026-07-01	Warnings	Exact identifier application number: M016
Drs. Pharmacy healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	55947cd9-ca25-0844-e063-6294a90a381f	2026-07-01	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	55833e0f-d184-16a2-e063-6394a90acfd3	2026-06-30	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55664a0f-7d46-f002-e063-6394a90a2dc7	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5566bce3-fc49-5ef4-e063-6294a90abc7a	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5568ada5-3ae6-3366-e063-6294a90a7119	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55698d88-aae7-c46c-e063-6394a90ad0ac	2026-06-29	Warnings	Exact identifier application number: M016
Earth Baby Diaper Rash Cream	ZINC OXIDE	Earth Baby, Inc	42c5cf9a-0a35-5681-e054-00144ff8d46c	2026-06-28	Warnings	Exact identifier application number: M016
ORLASKIN HYDROGEL EYE MASK	ALLANTOIN	Guangzhou Yapheon Health Industry Co., Ltd.	552d072b-396f-c88a-e063-6294a90aabcd	2026-06-26	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM	Medline Industries, LP	3c442890-733d-8175-e063-6294a90a8b1c	2026-06-24	Warnings	Exact identifier application number: M016
MOROVAN	ESTRIOL	HONG KONG UNORDERED TRADING CO., LIMITED	54fa4308-44a4-e9dd-e063-6394a90a0cd7	2026-06-24	Warnings	Exact identifier application number: M016
EELHOE Sleep Aid Patch	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	550b0494-ca6d-c897-e063-6394a90a8751	2026-06-24	Warnings	Exact identifier application number: M016
Hair Regrowth Liquid	GLYCERIN	Shantou Woodsleep Biotechnology Co., Ltd.	54e662e7-9c63-ad6b-e063-6294a90a1b8d	2026-06-23	Warnings	Exact identifier application number: M016
RoyceDerm Eczema Relief Body Wash	COLLOIDAL OATMEAL 2%	RoyceDerm LLC	54e74eb4-1b42-a748-e063-6394a90aeb16	2026-06-23	Warnings	Exact identifier application number: M016
Comfort Shield Barrier	DIMETHICONE	Sage Products LLC	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	2026-06-23	Warnings	Exact identifier application number: M016
CLEAR ANTI ITCH	PRAMOXINE HCL, ZINC ACETATE LOTION	H E B	54f04056-d805-8c62-e063-6394a90ab740	2026-06-23	Warnings, Adverse reactions	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