FDA.reportPublic FDA data

Iodine Tincture

Product NDC
76162-088
11-digit product format
761620088
Labeler code
76162
Product ID
76162-088_4ab7e252-0dd3-7c2f-e063-6394a90ab6b2
Type
HUMAN OTC DRUG
Nonproprietary name
Iodine Tincture
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-15
Substance
IODINE
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Iodine Tincture
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IODINE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9679TC07X4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311093Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e648f206-cc4f-4f5f-b31c-2fb8bf2708a7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-088-10Iodine Tincture30 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-088IODINE TINCTURE SOLUTION/ DROPS [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 1 package rows20240731_e648f206-cc4f-4f5f-b31c-2fb8bf2708a7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 69 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2869cb20-9cd4-54f5-e063-6294a90a5fea2025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Vanilla Sugar 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.28694168-3362-de4f-e063-6394a90a2e352025-09-05WarningsExact identifier
application number: M003
Smart Care Cucumber Melon Hand SanitizerALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e0a5382-7b58-fd6e-e063-6394a90abf662025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e09c0aa-0241-0816-e063-6294a90a481e2025-09-05WarningsExact identifier
application number: M003
Smart Care Sweet Pea Hand Sanitizer sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3080d8a2-a780-e79b-e063-6294a90ac6542025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3081e1b5-66b4-77a8-e063-6394a90a8dd32025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Island Mango 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.30847dd5-e378-1a35-e063-6294a90a43da2025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Vanilla Heaven 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3084d980-29ca-91ca-e063-6294a90a6c672025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3099e6af-8072-d26b-e063-6394a90a39ef2025-09-05WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE IODINESion Biotext Medical Ltde05af551-647d-4278-bb7f-86f888ddbb8b2025-09-04WarningsExact identifier
application number: M003
X3 CleanBENZALKONIUM CHLORIDEX3 Labs Inc.a8eedcfd-3b97-497a-9a34-d59b0dd784392025-09-03WarningsExact identifier
application number: M003
X3 CleanBENZALKONIUM CHLORIDEX3 Labs Inc.40cc6501-3cee-24cc-e054-00144ff88e882025-09-03WarningsExact identifier
application number: M003
5OCT ANTIBACTERL HAND WIPES5OCT ANTIBACTERL HAND WIPESJinhua Aidi Daily Chemical Co., Ltd.3dbd8ca9-1ca0-ac4f-e063-6394a90a3cfa2025-09-01WarningsExact identifier
application number: M003
AeroWipeSTING RELIEF PADAero Healthcare US LLC3d851c98-c9b9-f084-e063-6294a90acde22025-08-29WarningsExact identifier
application number: M003
wet wipes 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.3d3d7e8b-1ec1-9f9f-e063-6294a90ade0e2025-08-25WarningsExact identifier
application number: M003
Solar Flare Hand Sanitizer Brazilian Caramel DreamsALCOHOLScent Theory Products LLC3d0d4ccf-ea31-cab2-e063-6294a90a4c692025-08-23WarningsExact identifier
application number: M003
Solar Flare Hand Sanitizer Sunset SambaALCOHOLScent Theory Products LLC3d0d7d6b-33a0-5cd1-e063-6394a90ac8f62025-08-23WarningsExact identifier
application number: M003
Solar Flare Hand Sanitizer Set Sea Veil, Pink Glow, Coco CremeALCOHOLScent Theory Products LLC3d0d7e73-8a83-9577-e063-6294a90aff6c2025-08-23WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCfe439c60-5a02-648f-e053-6294a90a14032025-08-23WarningsExact identifier
application number: M003
OP-First Aid Series ALCOHOL PREP PADS STERILEISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co.,Ltd.351f4b1e-75c9-abec-e063-6294a90a28752025-08-22WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311093iodine 2 % Topical SolutionPSNe648f206-cc4f-4f5f-b31c-2fb8bf2708a76
311093iodine 20 MG/ML Topical SolutionSCDe648f206-cc4f-4f5f-b31c-2fb8bf2708a76
311093iodine 2 % tincture for Topical SolutionSYe648f206-cc4f-4f5f-b31c-2fb8bf2708a76
311093iodine 2 % Topical SolutionSYe648f206-cc4f-4f5f-b31c-2fb8bf2708a76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-088-107616200881030 mL in 1 BOTTLE, PLASTIC (76162-088-10) 30 ml2022-09-150000-00-00NoNoCurrent