Terranea Cares Wellness Kit

Product NDC: 69491-304
11-digit product format: 694910304
Labeler code: 69491
Product ID: 69491-304_d6fa05fd-4fdb-6480-e053-2995a90a5156
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: KIT
Labeler: Buzz Export Services Pty., Ltd.
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-09-30
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69491-304		I	Inactivated by FDA		2026-10-05
excluded package	package	69491-304	69491-304-00	I	Inactivated by FDA		2026-10-05

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 · 30 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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`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	69491-304-00	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69491-304-00	2024-01-30	C162847	48780-1	d6a99b39-6183-a426-e053-dadaa90af4c2	Terranea Cares Wellness Kit
69491-304-00	2022-02-16	C162847	48780-1	d6a99b39-6183-a426-e053-dadaa90af4c2	Terranea Cares Wellness Kit
69491-304-00	2022-01-28	C162847	48780-1	d6a99b39-6183-a426-e053-dadaa90af4c2	Terranea Cares Wellness Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69491-301-00	Terranea Cares Wellness Kit	20 mL in 1 BOTTLE	GEL	20 mL	0.75 mL in 1mL	2
69491-303-00	Terranea Cares Wellness Kit	1 in 1 PACKAGE	CLOTH		0.75 mL in 1mL	2
69491-303-00	Terranea Cares Wellness Kit	5 mL in 1 PATCH	CLOTH	5 mL	0.75 mL in 1mL	2
69491-304-00	Terranea Cares Wellness Kit	1 in 1 KIT	KIT	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69491-304	TERRANEA CARES WELLNESS KIT (ALCOHOL) KIT [BUZZ EXPORT SERVICES PTY., LTD.]	2	Legacy NDC, 4 package rows	20220217_af092aa3-d310-4046-e053-2995a90ae2d9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1307051	ethanol 75 % Medicated Pad	PSN	af092aa3-d310-4046-e053-2995a90ae2d9	2
1305100	ethanol 75 % Topical Gel	PSN	af092aa3-d310-4046-e053-2995a90ae2d9	2
1307051	ethanol 0.75 ML/ML Medicated Pad	SCD	af092aa3-d310-4046-e053-2995a90ae2d9	2
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	af092aa3-d310-4046-e053-2995a90ae2d9	2
1307051	ethanol 75 % Hand Sanitizer Wipes	SY	af092aa3-d310-4046-e053-2995a90ae2d9	2
1305100	ethanol 75 % Topical Gel	SY	af092aa3-d310-4046-e053-2995a90ae2d9	2
1307051	ethyl alcohol 75 % Topical Cloth	SY	af092aa3-d310-4046-e053-2995a90ae2d9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69491-301-00	69491030100	20 mL in 1 BOTTLE	20 ml					Historical
69491-303-00	69491030300	1 in 1 PACKAGE						Historical
69491-304-00	69491030400	1 KIT in 1 KIT (69491-304-00) * 20 mL in 1 BOTTLE (69491-301-00) * 1 PATCH in 1 PACKAGE (69491-303-00) > 5 mL in 1 PATCH	1 kit	2020-09-30	0000-00-00	No	No	Current