FDA.reportPublic FDA data

Colgate Optic White Advanced Icy Fresh

Product NDC
35000-977
11-digit product format
350000977
Labeler code
35000
Product ID
35000-977_79bceee3-222f-4872-a467-cdcf87888b7b
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-14
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
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
Colgate Optic White Advanced Icy Fresh
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f95496e3-11ec-4cd6-b3ee-cf6c657b790bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-977-32Colgate Optic White Advanced Icy Fresh90 g in 1 TUBEPASTE, DENTIFRICE903
35000-977-32Colgate Optic White Advanced Icy Fresh1 in 1 CARTONPASTE, DENTIFRICE13
35000-977-44Colgate Optic White Advanced Icy Fresh2 in 1 CARTONPASTE, DENTIFRICE23
35000-977-44Colgate Optic White Advanced Icy Fresh127 g in 1 TUBEPASTE, DENTIFRICE1273
35000-977-76Colgate Optic White Advanced Icy Fresh2 in 1 CARTONPASTE, DENTIFRICE23
35000-977-76Colgate Optic White Advanced Icy Fresh90 g in 1 TUBEPASTE, DENTIFRICE903
35000-977-86Colgate Optic White Advanced Icy Fresh127 g in 1 TUBEPASTE, DENTIFRICE1273
35000-977-86Colgate Optic White Advanced Icy Fresh1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-977COLGATE OPTIC WHITE ADVANCED ICY FRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]3Current NDC, Legacy NDC, 8 package rows20241215_f95496e3-11ec-4cd6-b3ee-cf6c657b790b.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 9 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Restore and DefendSTANNOUS FLUORIDEWalgreense808ea4b-9081-085b-e053-2a95a90a4f9b2026-06-02WarningsExact identifier
application number: M021
Hello Unicorn Splash unicorn splash anticavity fluoride rinseSODIUM FLUORIDEColgate-Palmolive Companya1014431-7d23-aaff-6dc7-ab58683d03382026-06-02WarningsExact identifier
application number: M021
Therabreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.feab3d45-ff95-4b32-8258-7d932a7380c92026-06-01WarningsExact identifier
application number: M021
Orajel Toy Story 5 AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.4b80947d-f389-2f80-e063-6294a90abd552026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.54113245-0c1e-739e-e063-6294a90aea422026-06-01WarningsExact identifier
application number: M021
Arm and HammerSODIUM FLUORIDEChurch & Dwight Co., Inc.545258fd-8179-fffc-e063-6394a90a467f2026-06-01WarningsExact identifier
application number: M021
Orajel Paw PatrolSODIUM FLUORIDEChurch & Dwight Co., Inc.99d87bea-3e99-5d04-e053-2a95a90aaf542026-06-01WarningsExact identifier
application number: M021
Orajel SuperMarioANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.27d2f6cb-8661-da9c-e063-6394a90a5bde2026-06-01WarningsExact identifier
application number: M021
Orajel KidsToothpasteSODIUM FLUORIDEChurch & Dwight Co., Inc.99d62125-c2c5-5926-e053-2995a90aaa292026-06-01WarningsExact identifier
application number: M021
AIM CAVITY PROTECTION Multi BenefitSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0f8a33-0b01-40e2-e054-00144ff88e882026-06-01WarningsExact identifier
application number: M021
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560980ea-749f-593d-e063-6394a90a1b9e2026-06-01WarningsExact identifier
application number: M021
Colgate Revitalizing WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyc67223ae-b068-41c5-a15b-7ae9840b93ef2026-05-27WarningsExact identifier
application number: M021
Colgate Kids Harry PotterSODIUM FLUORIDEColgate-Palmolive Company61c06da4-9f02-4fbc-b80f-1c443e2984962026-05-26WarningsExact identifier
application number: M021
sodium fluoride rinseSODIUM FLUORIDE RINSERockland Cosmetics, Inc.52430b12-4d5f-d1e1-e063-6394a90abd642026-05-20Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E Bd0a52519-3339-40ea-93e5-78f76d348a4d2026-05-14Warnings, Adverse reactionsExact identifier
application number: M021
Burts Bees Extra WhiteSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc92524fd-8b93-592d-e053-2a95a90a88c62026-05-13WarningsExact identifier
application number: M021
MIPaste Plus StrawberrySODIUM FLUORIDEGC America Inc.1b68bd67-65d3-4c64-e054-00144ff8d46c2026-05-12WarningsExact identifier
application number: M021
White Glo Purple Color Corrector Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc6f8b77c3-9833-4c75-b41c-a2bc126161572026-05-12WarningsExact identifier
application number: M021
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
application number: M021
Morning Fresh Mint Toothpaste, with FluorideMORNING FRESH MINT TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a42d8ce-e7f2-caa5-e063-6294a90ac01f2026-05-07WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNf95496e3-11ec-4cd6-b3ee-cf6c657b790b3
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDf95496e3-11ec-4cd6-b3ee-cf6c657b790b3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYf95496e3-11ec-4cd6-b3ee-cf6c657b790b3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYf95496e3-11ec-4cd6-b3ee-cf6c657b790b3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYf95496e3-11ec-4cd6-b3ee-cf6c657b790b3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYf95496e3-11ec-4cd6-b3ee-cf6c657b790b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-977-32350000977321 TUBE in 1 CARTON (35000-977-32) / 90 g in 1 TUBE1 tube2019-10-140000-00-00NoNoCurrent
35000-977-44350000977442 TUBE in 1 CARTON (35000-977-44) / 127 g in 1 TUBE2 tube2019-10-140000-00-00NoNoCurrent
35000-977-76350000977762 TUBE in 1 CARTON (35000-977-76) / 90 g in 1 TUBE2 tube2019-10-140000-00-00NoNoCurrent
35000-977-86350000977861 TUBE in 1 CARTON (35000-977-86) / 127 g in 1 TUBE1 tube2019-10-140000-00-00NoNoCurrent