Lipidol

Product NDC: 69359-000
11-digit product format: 693590000
Labeler code: 69359
Product ID: 69359-000_e7c5fce0-d31f-4114-b8ea-610bef25431a
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form: OIL
Route: TOPICAL
Labeler: UNION-SWISS (PTY) LTD
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-11-07
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 3 g/100mL; g/100mL; g/100mL; g/100mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69359-000		I	Inactivated by FDA		2026-08-03
excluded package	package	69359-000	69359-000-00	I	Inactivated by FDA		2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69359-000-00	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69359-000-00	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69359-000-00	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69359-000-00	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69359-000-00	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69359-000-00	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69359-000-00	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69359-000-00	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69359-000-00	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69359-000-00	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69359-000-00	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69359-000-00	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69359-000-00	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69359-000-00	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69359-000-00	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69359-000-00	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69359-000-00	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69359-000-00	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69359-000-00	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69359-000-00	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69359-000-00	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69359-000-00	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69359-000-00	2020-01-31	C162847	48780-1	9d75b9cf-fbe7-f424-e053-dadaa90a57ce	a500a64b-319f-476f-ac38-1648b587acf5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69359-000-00	Lipidol	125 mL in 1 BOTTLE	OIL	125		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
.BETA.-SITOSTEROL	INACTIVE INGREDIENT	S347WMO6M4	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
ALOE VERA FLOWER	INACTIVE INGREDIENT	575DY8C1ER	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
ASPARTIC ACID	INACTIVE INGREDIENT	30KYC7MIAI	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
AZADIRACHTA INDICA WHOLE	INACTIVE INGREDIENT	MRL4DVG1F6	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
BORAGO OFFICINALIS SEED	INACTIVE INGREDIENT	2GXJ790US0	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
CERAMIDE 1	INACTIVE INGREDIENT	5THT33P7X7	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
CETEARYL ETHYLHEXANOATE	INACTIVE INGREDIENT	9M64UO4C25	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
COCCINIA GRANDIS FRUIT	INACTIVE INGREDIENT	VLJ6WOT3K5	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
CORALLINA OFFICINALIS	INACTIVE INGREDIENT	4004498D06	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
CUPRESSUS SEMPERVIRENS LEAF OIL	INACTIVE INGREDIENT	M7QUY89S4O	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
CURCUMA LONGA WHOLE	INACTIVE INGREDIENT	W5488JUO8U	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
FARNESOL	INACTIVE INGREDIENT	EB41QIU6JL	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
GAMMA ORYZANOL	INACTIVE INGREDIENT	SST9XCL51M	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
GLUTAMIC ACID	INACTIVE INGREDIENT	3KX376GY7L	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
LAWSONIA INERMIS WHOLE	INACTIVE INGREDIENT	W7M7338R56	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
LIMONENE, (+)-	INACTIVE INGREDIENT	GFD7C86Q1W	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
LINOLEIC ACID	INACTIVE INGREDIENT	9KJL21T0QJ	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
LINOLENIC ACID	INACTIVE INGREDIENT	0RBV727H71	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
OCIMUM BASILICUM WHOLE	INACTIVE INGREDIENT	P4815JL4O3	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
OCIMUM TENUIFLORUM WHOLE	INACTIVE INGREDIENT	7OS52KZ33J	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
PYRIDOXINE DIPALMITATE	INACTIVE INGREDIENT	HB49XCT029	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
SAFFLOWER SEED	INACTIVE INGREDIENT	8FCL6A31TX	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2
SOLANUM MELONGENA WHOLE	INACTIVE INGREDIENT	5DS5EE0N93	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69359-000	LIPIDOL (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [UNION-SWISS (PTY) LTD]	2	Legacy NDC, 1 package rows	20151124_a500a64b-319f-476f-ac38-1648b587acf5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69359-000-00	69359000000	125 mL in 1 BOTTLE	125 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lipidol - UNION-SWISS (PTY) LTD \| COLUMBIA PHARMACEUTICALS (PTY) LTD	UNION-SWISS (PTY) LTD \| COLUMBIA PHARMACEUTICALS (PTY) LTD	2015-11-24	HUMAN OTC DRUG LABEL	2