FDA.reportPublic FDA data

Simply Saline

Product NDC
10237-700
11-digit product format
102370700
Labeler code
10237
Product ID
10237-700_3855eab5-57ab-b144-e063-6294a90a8bc5
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride 0.13%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Church & Dwight Co., Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-01
Substance
BENZETHONIUM CHLORIDE
Active strength
1 mg/13mL
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
Simply Saline
Brand name suffix
Wound Care
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE1 mg/13mL

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
6c802e91-b69e-cdd0-e053-2991aa0aa781Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-700-71Simply SalineWound Care211 mL in 1 CANSPRAY2113
10237-700-72Simply SalineWound Care211 mL in 1 CANSPRAY2113
10237-700-72Simply SalineWound Care2 in 1 PACKAGESPRAY23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-700SIMPLY SALINE WOUND CARE (BENZETHONIUM CHLORIDE 0.13%) SPRAY [CHURCH & DWIGHT CO., INC.]2Current NDC, Legacy NDC, 3 package rows20241123_6c802e91-b69e-cdd0-e053-2991aa0aa781.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 34 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLTopco Associates LLCbe4f41bd-8a75-4fb6-8d28-67f6f853e6bd2026-02-11Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLTopco Associates LLC9fbded5f-8dc1-4134-a711-48d1a581d8742026-02-11Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLTopco Associates LLCad1ef2ea-bfc3-4a8a-acd2-55e7f52813d42026-02-11Warnings, Adverse reactionsExact identifier
application number: M003
Antibacterial Wet wipesBENZALKONIUM CHLORIDEZhejiang Easyclean Daily Chemical Co., Ltd.a1cb6ac9-95f5-3ef1-e053-2a95a90abcdf2026-02-11WarningsExact identifier
application number: M003
Universal ISOPROPYL Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC0c76f14b-9a0c-4573-96f2-cd4080eb99e62026-02-10WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLWalgreen Co.a08ef11f-5c4f-4821-a0c0-d6c89def0bea2026-02-10Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLWalgreen Co.fb918e7a-1fe0-4cfd-8cf0-9d823eb56dcc2026-02-10Warnings, Adverse reactionsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.49e31509-d489-44be-e063-6394a90a97ef2026-02-10WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VMY IMPORTS USA LLC4a849c4f-9b96-6b20-e063-6394a90a34862026-02-10WarningsExact identifier
application number: M003
MedlineISOPROPYL ALCOHOLHy-Vee, Inc.4bbce274-1e62-0c6a-e063-6394a90af92f2026-02-10WarningsExact identifier
application number: M003
Everlit Care Products Antiseptic WipeANTISEPTIC WIPEEVERLIT GLOBAL INC.3331e2f1-c3d0-41fc-a792-be5dcdf4e24a2026-02-09WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS PREP PADISOPROPYL ALCOHOLEVERLIT GLOBAL INC.77a60360-8bb5-43e9-b7e4-f71d2d488c442026-02-09WarningsExact identifier
application number: M003
Everlit Care Products Sting ReliefISOPROPYL ALCOHOLEVERLIT GLOBAL INC.adfab206-b7de-4f6a-a864-edd946ea743d2026-02-09WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS IODINE PREP PADPOVIDONE-IODINEEVERLIT GLOBAL INC.5cbdb73d-333a-4244-a1c0-be430632f0ed2026-02-09WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLA-S Medication Solutions6b8834be-0235-4f7c-8d52-c2f6aa2d30492026-02-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDESalado Sales Inc.78a46975-568a-4a88-8597-9603b8bbf9352026-02-06Warnings, Adverse reactionsExact identifier
application number: M003
70% RubbingISOPROPYL ALCOHOLWalgreens Co.6ad37d18-5c19-4b5f-8313-edd430f84fb02026-02-05Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLWalgreens Co.1473e6e4-dc5f-43d9-a249-111a181e3f762026-02-05Warnings, Adverse reactionsExact identifier
application number: M003
Aquarrelle Antibacterial Wipes 40BENZALKONIUM CHLORIDEKimberly-Clark De Mexico, S.A.B.deC.V.3584680e-71b0-23b6-e063-6294a90a69982026-02-05WarningsExact identifier
application number: M003
Aquarrelle Antibacterial Wipes 20BENZALKONIUM CHLORIDEKimberly-Clark De Mexico, S.A.B.deC.V.35865d33-a99f-1b37-e063-6394a90a00d22026-02-05WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-700-7110237070071211 mL in 1 CAN (10237-700-71) 211 ml2018-05-180000-00-00NoNoCurrent
10237-700-72102370700722 CAN in 1 PACKAGE (10237-700-72) / 211 mL in 1 CAN2 can2025-06-01NoNoCurrent