FDA.reportPublic FDA data

Dr. Johne SKIN TAG REMOVER

Product NDC
85818-001
11-digit product format
858180001
Labeler code
85818
Product ID
85818-001_9b9187e3-9ed3-4fc9-aa61-fdeb3dd0bee8
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Dr.Johnes LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-02
Substance
SALICYLIC ACID
Active strength
170 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
Dr. Johne SKIN TAG REMOVER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID170 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312881Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6c5adc3c-9d45-449a-ad42-f9571851cd18Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85818-001-01Dr. Johne SKIN TAG REMOVER10 mL in 1 TUBESOLUTION109
85818-001-02Dr. Johne SKIN TAG REMOVER7 mL in 1 TUBESOLUTION79
85818-001-03Dr. Johne SKIN TAG REMOVER8 mL in 1 TUBESOLUTION89
85818-001-04Dr. Johne SKIN TAG REMOVER9 mL in 1 TUBESOLUTION99

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 43 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
application number: M016
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
application number: M016
Gold Bond Eczema Relief Medicated Hand CreamCOLLOIDAL OATMEALChattem, Inc.27457bc5-3edc-4c8b-b8a2-eaf09b511cf82025-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD30a977c3-6862-670e-e063-6294a90aeb2f2025-03-18WarningsExact identifier
application number: M016
YVTYVT Copper Peptides Face SerumCOPPER TRIPEPTIDE-1Beijing JUNGE Technology Co., Ltd.306f2d48-43b8-359a-e063-6394a90a06dc2025-03-16Boxed warning, WarningsExact identifier
application number: M016
Dr Talbots Cooling Perineal PadWATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATETalbot's Pharmaceuticals family Products, LLC.242277e2-ff26-ad4e-e063-6394a90ab3172025-03-14WarningsExact identifier
application number: M016
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
application number: M016
Aavini Double Layer Brightening Spot Correcting Essence OilAAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OILQingyuan Moksha Biotechnology Co., Ltd.2ff89a13-3969-2df1-e063-6394a90ac0d32025-03-10WarningsExact identifier
application number: M016
5% Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3008bbeb-abba-5cdb-e063-6294a90ae4832025-03-10WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber MelonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2fc4745c-fac9-7861-e063-6294a90a3f142025-03-07WarningsExact identifier
application number: M016
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Nighttime BalmOATMEALKenvue Brands LLC04d90e45-c2ee-4122-b919-a0eb6d11b59a2025-03-04WarningsExact identifier
application number: M016
5% Signature Numb cream5% SIGNATUREShengnan (Guangzhou) Cosmetics Co., LTD2f80abc0-49d8-968d-e063-6294a90a555b2025-03-04WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf19b3056-063c-63ec-e053-2995a90a46142025-03-04WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint TwistCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2770424d-7414-66d4-e063-6394a90ad4b12025-03-04WarningsExact identifier
application number: M016
Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-FreeCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company026bb3a1-3e01-1530-e063-6294a90ab1b12025-03-04WarningsExact identifier
application number: M016
5% Dr.care Numb creamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD2f905d76-ef9c-c844-e063-6394a90a4dc92025-03-04WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1590101a-c968-fca5-e063-6394a90a7ccc2025-02-28WarningsExact identifier
application number: M016
Perineal Cooling LinersWITCH HAZELCVS Pharmacy88f44650-8fb7-4eb2-901d-30eb8415dc2b2025-02-25WarningsExact identifier
application number: M016
5% Signature Numb creamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD2f043d3c-d8db-414e-e063-6394a90a13de2025-02-25WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312881salicylic acid 17 % Topical SolutionPSN6c5adc3c-9d45-449a-ad42-f9571851cd189
312881salicylic acid 170 MG/ML Topical SolutionSCD6c5adc3c-9d45-449a-ad42-f9571851cd189
312881salicylic acid 17 % Topical SolutionSY6c5adc3c-9d45-449a-ad42-f9571851cd189

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85818-001-018581800010110 mL in 1 TUBE (85818-001-01) 10 ml2025-06-02NoNoCurrent
85818-001-02858180001027 mL in 1 TUBE (85818-001-02) 7 ml2025-06-02NoNoCurrent
85818-001-03858180001038 mL in 1 TUBE (85818-001-03) 8 ml2025-06-02NoNoCurrent
85818-001-04858180001049 mL in 1 TUBE (85818-001-04) 9 ml2025-06-02NoNoCurrent