OLOGY

Product NDC
0363-3560
11-digit product format
003633560
Labeler code
0363
Product ID
0363-3560_6abadab3-868b-43eb-968d-f0b2eea9ba10
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
WALGREEN COMPANY
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-04-05
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
0 g/g; g/g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct0363-3560IInactivated by FDA2026-10-05
excluded packagepackage0363-35600363-3560-02IInactivated 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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-3560-02IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-3560-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-3560-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-3560-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-3560-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-3560-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-3560-02IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-3560-02IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-3560-02IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-3560-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0363-3560-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0363-3560-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0363-3560-02IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0363-3560-02IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0363-3560-02IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0363-3560-02IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0363-3560-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0363-3560-02IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0363-3560-02IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0363-3560-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0363-3560-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0363-3560-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-3560-022020-01-31C16284748780-19d75b9d0-b41f-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3560-02OLOGY57 g in 1 BOTTLE, PLASTICLOTION571

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
ACACIAINACTIVE INGREDIENT5C5403N26OOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
CARTHAMUS TINCTORIUS SEED OLEOSOMESINACTIVE INGREDIENT9S60Q72309OLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNAOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
COMFREY ROOTINACTIVE INGREDIENTM9VVZ08EKQOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3POLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJYOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62OLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
ROYAL JELLYINACTIVE INGREDIENTL497I37F0COLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
SUCROSE DISTEARATEINACTIVE INGREDIENT33X4X4B90SOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0ROLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEOLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3560OLOGY (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WALGREEN COMPANY]1Legacy NDC, 1 package rows20130409_1cb6bf0f-b410-4da6-acbd-103da6e9c959.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0363-3560-020036335600257 g in 1 BOTTLE, PLASTIC57 gHistorical