Outback 2-in-1

Product NDC: 43979-445
11-digit product format: 439790445
Labeler code: 43979
Product ID: 43979-445_3b04cd1f-ed03-47df-9315-1a085ec373c1
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate,4-Methylbenzylidene Camphor and Zinc
Dosage form: CREAM
Route: TOPICAL
Labeler: Elmore Oil Company Pty Ltd
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2012-07-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; ENZACAMENE; ZINC OXIDE
Active strength: 90 mg/mL; mg/mL; mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43979-445		I	Inactivated by FDA	2026-09-14
excluded package	package	43979-445	43979-445-01	I	Inactivated by FDA	2026-09-14
excluded package	package	43979-445	43979-445-03	I	Inactivated by FDA	2026-09-14

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 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43979-445-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43979-445-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43979-445-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43979-445-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43979-445-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43979-445-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43979-445-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43979-445-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43979-445-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43979-445-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43979-445-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43979-445-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43979-445-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43979-445-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43979-445-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43979-445-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43979-445-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43979-445-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43979-445-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43979-445-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43979-445-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43979-445-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43979-445-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43979-445-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43979-445-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43979-445-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43979-445-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43979-445-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43979-445-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43979-445-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43979-445-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43979-445-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43979-445-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43979-445-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43979-445-03	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43979-445-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43979-445-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43979-445-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43979-445-03	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43979-445-01	`e2bbac7714bc…`	`27bdfed8d636…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43979-445-01	2019-11-13	C162847	48780-1	97449f38-c0da-f6ea-e053-dbdaa90aa703	ea926d9b-7bb5-4480-98b8-d80e4b3f1a67
43979-445-03	2019-11-13	C162847	48780-1	97449f38-c0da-f6ea-e053-dbdaa90aa703	ea926d9b-7bb5-4480-98b8-d80e4b3f1a67

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43979-445-01	Outback 2-in-1Insect Repellent and Protective Sunscreen	3 mL in 1 POUCH	CREAM	3		1
43979-445-03	Outback 2-in-1Insect Repellent and Protective Sunscreen	50 mL in 1 BOTTLE	CREAM	50		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ENZACAMENE	ACTIVE INGREDIENT	8I3XWY40L9	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1
ENZACAMENE	ACTIVE MOIETY	8I3XWY40L9	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1
EUCALYPTUS POLYBRACTEA LEAF OIL	INACTIVE INGREDIENT	J1XGA6WROO	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1
LEPTOSPERMUM PETERSONII LEAF OIL	INACTIVE INGREDIENT	N37UWG52T3	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43979-445	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1	Legacy NDC, 2 package rows	20120701_ea926d9b-7bb5-4480-98b8-d80e4b3f1a67.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
8I3XWY40L9	ENZACAMENE	36861-47-9	ENZACAMENE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
43979-445-01	43979044501	3 mL in 1 POUCH	3 ml	Historical
43979-445-03	43979044503	50 mL in 1 BOTTLE	50 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Octinoxate,4-Methylbenzylidene Camphor and Zinc - Elmore Oil Company Pty Ltd	Elmore Oil Company Pty Ltd	2012-06-11	HUMAN OTC DRUG LABEL	1