FDA.reportPublic FDA data

Sterilized wet wipes

Product NDC
82061-007
11-digit product format
820610007
Labeler code
82061
Product ID
82061-007_5047a3bc-f0eb-44f4-e063-6394a90a76e7
Type
HUMAN OTC DRUG
Nonproprietary name
Sterilized wet wipes
Dosage form
PATCH
Route
TOPICAL
Labeler
Shandong Aishule Hygiene Products Co., Ltd
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-26
Substance
BENZETHONIUM CHLORIDE
Active strength
.0018 g/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
Sterilized wet wipes
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE.0018 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7ca1799-eee4-66f0-e053-6294a90a273fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82061-007-022024-01-30C16284748780-11030e365-1c46-111a-e063-dadaa90a10e2f7ca1799-eee4-66f0-e053-6294a90a273f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82061-007-01Sterilized wet wipes3.3 g in 1 PATCHPATCH3.34
82061-007-02Sterilized wet wipes80 in 1 PATCHPATCH804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82061-007STERILIZED WET WIPES PATCH [SHANDONG AISHULE HYGIENE PRODUCTS CO., LTD]3Current NDC, 2 package rows20250316_f7ca1799-eee4-66f0-e053-6294a90a273f.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 27 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BisacodylBISACODYL SUPPOSITORIESOncor Pharmaceuticals6f0aefc9-cd5f-4bdd-89c2-b6a80558987c2025-01-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.2c65319f-6cf5-aa90-e063-6394a90ad6622025-01-23WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECardinal Health (Leader) 70000cde87f95-73c0-46f5-9349-37e04096048c2025-01-22WarningsExact identifier
application number: M007
Senna-TabsSENNA 8.6MGUlai Health LLC485129a0-8340-4f61-be51-5abff5032b8d2025-01-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILTopco Associates, LLC0609468d-ee66-49af-be40-e51965b88f6f2025-01-20WarningsExact identifier
application number: M007
Soluble FiberMETHYLCELLULOSEUnited Natural Foods, Inc. dba UNFI6decd5ef-e8e1-44ae-8465-6266cf18e81e2025-01-20WarningsExact identifier
application number: M007
PerdiemSENNOSIDES, STIMULANT LAXATIVEHaleon US Holdings LLC6b256c8f-3953-4c69-9a16-ffa0511bdbcd2025-01-16WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESEverpharm LLC0ea9f2b5-4533-4b71-b019-10ecb3c064592025-01-16WarningsExact identifier
application number: M007
Anecream 5LIDOCAINE 5%Focus Health Group1810edc3-093e-402f-bcb0-9c731da283a72025-01-15WarningsExact identifier
application number: M007
SennaSENNOSIDESReliable 1 Laboratories LLCae46a611-20f2-74c8-e053-2995a90a32ce2025-01-15WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMReliable-1 Laboratories LLCa97a1829-f62f-2014-e053-2a95a90a8cc52025-01-15WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs4d678da0-9ada-4d00-9db9-33b45c7761072025-01-15WarningsExact identifier
application number: M007
Goodsense Fiber laxative 147CALCIUM POLYCARBOPHILGoodSense17f5570b-be85-9dce-e063-6294a90abeaf2025-01-14WarningsExact identifier
application number: M007
Sunmark Mineral Oil LaxativeMINERAL OILStrategic Sourcing Servicesc54f7df2-3845-425f-b13e-3dc000123f3c2025-01-14WarningsExact identifier
application number: M007
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGUlai Health LLCc0e27b02-8ef2-4239-8f8c-790f7d978dc02025-01-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals1541ff5b-11f8-444b-a2a0-8e3086ae650a2025-01-10WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAvPAKf31a4349-7826-45c0-9388-6b938d167b7a2025-01-09WarningsExact identifier
application number: M007
Docusate sodiumDOCUSATE SODIUMAPNAR PHARMA LP05b0732b-012f-78ee-e063-6294a90a839a2025-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMMcKessone5fdfcfd-5340-4929-9f68-2696110cca8e2025-01-07WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILSHANDONG XINHUA PHARMACEUTICAL CO., LTD.ee06868b-f741-8da2-e053-2a95a90a97722025-01-02WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82061-007-01820610007013.3 g in 1 PATCH3.3 gHistorical
82061-007-028206100070280 PATCH in 1 PATCH (82061-007-02) / 3.3 g in 1 PATCH (82061-007-01) 80 patch2023-03-26NoNoCurrent