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		2026-10-23
excluded package	package	0178-0330	0178-0330-08	D	Discontinued by firm		2026-10-23

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 58 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BioBarrier Renewal Cream	ALLANTOIN	bluemercury	1ee15f84-0561-3cd2-e063-6394a90ab68e	2024-09-15	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Strategic Sourcing Services, LLC	22173332-9d09-768c-e063-6394a90a94e1	2024-09-14	Warnings	Exact identifier application number: M016
Diaper Rash Cream 5.6oz	ZINC OXIDE	China Ningbo Shangge Cosmetics Technology Corp.	21a7c4ce-1360-931c-e063-6294a90aa66d	2024-09-11	Warnings	Exact identifier application number: M016
Healing Cream 3oz	PETROLATUM	China Ningbo Shangge Cosmetics Technology Corp.	21bdbb13-cc64-b5d7-e063-6294a90ae3fd	2024-09-11	Warnings	Exact identifier application number: M016
Healing Cream15oz	PETROLATUM	Rejoice International Corp.	21e4026c-d3da-e4f7-e063-6394a90aabed	2024-09-11	Warnings	Exact identifier application number: M016
Baby Balm Stick 0.65oz	PETROLATUM OINTMENT	China Ningbo Shangge Cosmetics Technology Corp.	21c0b614-ea19-e98d-e063-6294a90ac44e	2024-09-10	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Moisturizing Fragrance Free	DIMETHICONE	Kenvue Brands LLC	65476a2a-8cd4-4477-ac27-9a06f41e4711	2024-09-09	Warnings	Exact identifier application number: M016
Diaper Rash Cream 15oz	ZINC OXIDE	Rejoice International Corp.	213213ab-f935-a62e-e063-6394a90af96b	2024-09-03	Warnings	Exact identifier application number: M016
Diaper Rash Cream 5.6oz	ZINC OXIDE	Rejoice International Corp.	2133876b-eaf0-f988-e063-6394a90aae4d	2024-09-03	Warnings	Exact identifier application number: M016
Baby Balm Stick 0.65oz	PETROLATUM	Rejoice International Corp.	20cf3bb8-4ab8-2980-e063-6294a90ad631	2024-08-29	Warnings	Exact identifier application number: M016
SUDOCREM SKIN PROTECTANT	ZINC OXIDE	LEDA INNOVATIONS USA, INC.	20d2cf0b-d237-fd78-e063-6394a90a8d03	2024-08-29	Warnings	Exact identifier application number: M016
Healing Cream 3oz	PETROLATUM	Rejoice International Corp.	20c9b964-c9af-d63a-e063-6294a90ab979	2024-08-28	Warnings	Exact identifier application number: M016
Babyganics Soothing Itch	OATMEAL	KAS Direct, LLC	5c2806fb-5af4-4532-b31a-be77bb23b277	2024-08-28	Warnings	Exact identifier application number: M016
Meijer Baby Petroleum Jelly Skin Protectant Frag Free	PETROLATUM	Meijer Distribution	0a0e6de8-b7c1-af7e-e063-6394a90a3ee2	2024-08-26	Warnings	Exact identifier application number: M016
Meijer Baby Petroleum Jelly Skin Protectant Fresh Scent	PETROLATUM	Meijer Distribution	0a0e9b39-9ce1-e788-e063-6294a90abf0b	2024-08-26	Warnings	Exact identifier application number: M016
Insect sting relief latex 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b9e2d4c-bc0c-6ed0-e063-6294a90a9103	2024-08-19	Warnings	Exact identifier application number: M016
Dove	CARE AND PROTECT ANTIBACTERIAL HAND WASH	Conopco Inc. d/b/a/ Unilever	b9f65122-4037-de0b-e053-2995a90ae510	2024-08-16	Warnings	Exact identifier application number: M016
BioBarrier Repair Eye Cream	ALLANTOIN	Bluemercury Inc.	1ee70a3c-76cc-335f-e063-6294a90a4f49	2024-08-04	Warnings	Exact identifier application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHED	ZINC OXIDE	Dabur India Ltd	1e6143c1-cd08-c171-e063-6394a90a2cee	2024-07-29	Warnings	Exact identifier application number: M016
HealthWise Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	1e189d97-2677-e8d7-e063-6394a90ac3d6	2024-07-25	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