BIRDS GARDEN LIP BALM

Product NDC
55143-010
11-digit product format
551430010
Labeler code
55143
Product ID
55143-010_9260c289-54ae-4eaf-b8f4-376959804993
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE
Dosage form
STICK
Route
TOPICAL
Labeler
Norwood Packaging Ltd.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE
Active strength
8 g/100g; g/100g; g/100g; g/100g
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55143-010IInactivated by FDA2026-10-05
excluded packagepackage55143-01055143-010-50IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55143-010-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55143-010-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55143-010-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55143-010-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55143-010-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55143-010-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55143-010-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55143-010-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55143-010-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55143-010-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55143-010-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55143-010-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55143-010-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55143-010-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55143-010-501332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55143-010-50fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55143-010-5086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55143-010-50bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55143-010-508dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55143-010-50e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55143-010-509bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55143-010-50110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55143-010-502019-10-29C16284748780-1960f7f55-cc98-8e05-e053-dbdaa90a074aLIP BALM ALOE & VITAMIN E UVA / UVB PROTECTION SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55143-010-50BIRDS GARDEN LIP BALM WESTERN TANAGER - SPF 304 g in 1 TUBESTICK41

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
OCTISALATEACTIVE MOIETY4X49Y0596WBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
LOW DENSITY POLYETHYLENEINACTIVE INGREDIENTJ245LN42AIBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
SACCHARININACTIVE INGREDIENTFST467XS7DBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177ABIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55143-010BIRDS GARDEN LIP BALM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND OXYBENZONE) STICK [NORWOOD PACKAGING LTD.]1Legacy NDC, 1 package rows20110323_70c5c98f-ca9d-4e1c-93ec-c6cdf03ab6ee.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55143-010-50551430010504 g in 1 TUBE4 gHistorical