FDA.reportPublic FDA data

NDC 21839-620-01 - COOLA Full Spectrum 360 Sun Silk Drops SPF 30

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
21839-620
Requested NDC
21839-620-01
Package NDCs from labels
21839-620-01, 21839-620-02, 21839-620-03, 21839-620-04
Manufacturer
Gordon Laboratories, Inc. | GORDON LABORATORIES,INC
Effective date
2019-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
WATER - Gordon Laboratories, Inc. | GORDON LABORATORIES,INCGordon Laboratories, Inc. | GORDON LABORATORIES,INC2019-12-18HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-620-022021-01-29C16284748780-1ba0f9c33-5e26-a910-e053-dadaa90a0b85COOLA Full Spectrum 360 Sun Silk Drops SPF 30
21839-620-042021-01-29C16284748780-1ba0f9c33-5e26-a910-e053-dadaa90a0b85COOLA Full Spectrum 360 Sun Silk Drops SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-620-01COOLA Full Spectrum 360 Sun Silk DropsSPF 305 mL in 1 BOTTLELIQUID51
21839-620-02COOLA Full Spectrum 360 Sun Silk DropsSPF 301 in 1 NOT APPLICABLELIQUID11
21839-620-03COOLA Full Spectrum 360 Sun Silk DropsSPF 3030 mL in 1 BOTTLELIQUID301
21839-620-04COOLA Full Spectrum 360 Sun Silk DropsSPF 301 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-620COOLA FULL SPECTRUM 360 SUN SILK DROPS SPF 30 (AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE) LIQUID [GORDON LABORATORIES, INC.]1Legacy NDC, 4 package rows20191224_9a03c1f7-098e-035d-e053-2a95a90a1fef.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 58 of 203 · 4,050 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
LemonGLYCERINSion Biotext Medical Ltddbd7ed86-1b92-4471-827a-89f3afa1b0dc2026-01-08WarningsExact identifier
unii: PDC6A3C0OX
CitraNatal 90 DHAVITAMIN C, CALCIUM, IRON, VITAMIN D3, VITAMIN E, THIAMIN, RIBOFLAVIN, NIACINAMIDE, VITAMIN B6, FOLIC ACID, IODINE, ZINC, COPPER, DOCUSATE SODIUMMission Pharmacal Company81e639d7-352e-4eaa-87d9-582da68b97282026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9E8X80D2L0
NIDA Invisible Fit SunscreenSUNSCREENProso Corp47ed3b62-45ef-b67a-e063-6294a90a317b2026-01-08WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
Glycerin Combination 9304GLYCERIN COMBINATIONProfessional Complementary Health Formulas391d8517-9b89-4b62-97b5-5102b35bec462026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Perfumox 6028PERFUMOXProfessional Complementary Health Formulasd27ac082-12fc-477d-a5c0-bb74f29c0e602026-01-08WarningsExact identifier
unii: D4BGE91OXH
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKDC/One Development Corporation, Inc.259f3fe3-2967-6c05-e063-6394a90a9e452026-01-07WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
CENTELLA RELIEF SOOTHING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEIUNIK Co., Ltd.47d170e3-dd76-d413-e063-6294a90ae8e42026-01-07WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Proactiv Clear Skin SPF 30AVOBENZONE, OCTISALATE, AND OCTOCRYLENEAlchemee, LLCb0aa7ff0-f712-486f-aaaf-f88fed3b5cd12026-01-07WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION7d9c0f81-005f-4223-940e-a64143db52752026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair ShirakabaOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION26151cf4-0fee-4a42-92fd-4d7b9cef83812026-01-06WarningsExact identifier
unii: 5A68WGF6WM
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION51f759b7-8c49-41d4-aaa3-f901d599cac52026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill)AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION463dc557-9743-4a38-969e-2c78fc10ee2a2026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION23bb4225-bfb5-47e2-80fe-733761ba40692026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
SHISEIDO WHITE LUCENT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONe881e637-e0f0-4c90-8343-2be6e74020b82026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Hawaiian Tropic Lip Balm Sunscreen SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7b71be3-f906-bd09-e053-2995a90adc612026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONd308d578-c881-4c10-8c79-9e3cd58b694c2026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX

Reported adverse events (FAERS/openFDA)#

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