FDA.reportPublic FDA data

Sulfur anti-mite shower gel

Product NDC
84509-034
11-digit product format
845090034
Labeler code
84509
Product ID
84509-034_2b3ee9e5-938d-a1dd-e063-6294a90a59c6
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Laureth Sulfat,Decyl Glucoside,Palm Kernelamide DEA,Cocamidopropyl Betaine,Lonicera Japonica(Honeysuckle) Flower Extract,Colloidal Sulfur.
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangdong Junhui Biotechnology Co., Ltd
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-23
Substance
SODIUM; LONICERA JAPONICA FLOWER; DECYL GLUCOSIDE; COCAMIDOPROPYL BETAINE; PALM KERNEL OIL; SULFUR
Active strength
25200; 10500; 5100; 3000; 3000; 600 mg/300mL; mg/300mL; mg/300mL; mg/300mL; mg/300mL; mg/300mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Sulfur anti-mite shower gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM25200 mg/300mL
LONICERA JAPONICA FLOWER10500 mg/300mL
DECYL GLUCOSIDE5100 mg/300mL
COCAMIDOPROPYL BETAINE3000 mg/300mL
PALM KERNEL OIL3000 mg/300mL
SULFUR600 mg/300mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9NEZ333N27Internal UNII lookup
4465L2WS4YInternal UNII lookup
Z17H97EA6YInternal UNII lookup
5OCF3O11KXInternal UNII lookup
B0S90M0233Internal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
251ee057-1adf-bc97-e063-6394a90acdd3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84509-034-01Sulfur anti-mite shower gel300 mL in 1 BOTTLELIQUID3002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84509-034SULFUR ANTI-MITE SHOWER GEL (SODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR.) LIQUID [GUANGDONG JUNHUI BIOTECHNOLOGY CO., LTD]2Current NDC, 1 package rows20250110_251ee057-1adf-bc97-e063-6394a90acdd3.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 54 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unilevered234413-777a-9c82-e053-2a95a90a6f982024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceCATCHING THE SUNRISE HAND SANITIZERConopco Inc. d/b/a/ Unileverb9fa6c72-7c56-6fd0-e053-2995a90a67072024-11-07WarningsExact identifier
application number: M016
DoveCARE AND PROTECT ANTIBACTERIAL FOAMING HAND WASHConopco Inc. d/b/a/ Unilevered24b320-27fc-9714-e053-2995a90a79a62024-11-07WarningsExact identifier
application number: M016
SKINSEIETHYL ALCOHOL LIQUIDConopco Inc. d/b/a/ Unilevera603c419-238f-0bae-e053-2a95a90abc2b2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceUNDER THE STARLIT SKY HAND SANITIZERConopco Inc. d/b/a/ Unileverba0dfe52-c550-94fd-e053-2995a90a98002024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSUMMERTIME SPRINKLERS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0e474c-db62-910f-e053-2995a90a889e2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceGIRLS NIGHT OUT HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ce03e-5e7b-b09a-e053-2995a90a4eef2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceAFTER THE RAIN HAND SANITIZERConopco Inc. d/b/a/ Unileverba0d27fb-f72f-5e87-e053-2a95a90af7e02024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED CATCUS FLOWER AND BASIL HAND SANITIZERConopco Inc. d/b/a/ Unileverba47599c-3e11-cec3-e053-2a95a90aef7b2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceWRAPPED IN YOUR ARMS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ef938-da18-3b9c-e053-2995a90acb722024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSUNKISSED OCEAN WAVES HAND SANITIZERConopco Inc. d/b/a/ Unileverba0db6a3-222a-093f-e053-2a95a90ac88a2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceLAZY WEEKENDS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0f4571-e752-d925-e053-2995a90afd3a2024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED GREEN CLAY AND EUCALYPTUS HAND SANITIZERConopco Inc. d/b/a/ Unileverba48b351-0d7f-5a41-e053-2a95a90a348c2024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED COCONUT AND WARM VANILLA HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ffbf9-7dd0-f685-e053-2995a90a0be02024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED PATCHOULI AND ORANGE FLOWER HAND SANITIZERConopco Inc. d/b/a/ Unileverba49e27b-1ade-a75a-e053-2a95a90a18432024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED CHERRY BLOSSOM AND TEA ROSE HAND SANITIZERConopco Inc. d/b/a/ Unileverba4979a3-ae30-42e4-e053-2995a90abfe72024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSWEET TREATS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0fa3cb-8c25-7511-e053-2995a90a42872024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED LAVENDER AND HYSSOP HAND SANITIZERConopco Inc. d/b/a/ Unileverba484531-ef7b-17ed-e053-2995a90a50b32024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED GRAPEFRUIT AND RED GINGER HAND SANITIZERConopco Inc. d/b/a/ Unileverba4a573d-def4-a735-e053-2995a90a4f292024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER LAVENDERConopco Inc. d/b/a/ Unileverddcb0871-9903-125f-e053-2a95a90a75de2024-11-07WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84509-034-0184509003401300 mL in 1 BOTTLE (84509-034-01) 300 ml2024-10-23NoNoCurrent