FDA.reportPublic FDA data

Aftaseptic

Product NDC
73635-7102
11-digit product format
736357102
Labeler code
73635
Product ID
73635-7102_5d6d95d2-d04f-ab4d-e063-6294a90a0575
Type
HUMAN OTC DRUG
Nonproprietary name
Salisylic Acid 1%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Germa Products, LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-29
Substance
SALICYLIC ACID
Active strength
10 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
Aftaseptic
Brand name suffix
Instant Pain Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID10 mg/mL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-05-09Aftaseptic Analgesic Liquid
2023-05-09Aftaseptic Analgesic Liquid
2023-05-09Aftaseptic Analgesic Liquid
2023-01-30Aftaseptic Analgesic Liquid
2023-01-30Aftaseptic Analgesic Liquid
2023-01-30Aftaseptic Analgesic Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73635-7102-5AftasepticInstant Pain Relief1 in 1 BOXLIQUID19
73635-7102-5AftasepticInstant Pain Relief14.8 mL in 1 BOTTLE, WITH APPLICATORLIQUID14.89

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73635-7102AFTASEPTIC INSTANT PAIN RELIEF (SALISYLIC ACID 1%) LIQUID [GERMA PRODUCTS, LLC]8Current NDC, Legacy NDC, 2 package rows20241017_beb32fba-503a-f5e5-e053-2a95a90a57e5.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047362salicylic acid 1 % Topical SolutionPSNbeb32fba-503a-f5e5-e053-2a95a90a57e59
1047362salicylic acid 10 MG/ML Topical SolutionSCDbeb32fba-503a-f5e5-e053-2a95a90a57e59
1047362salicylic acid 1 % Topical SolutionSYbeb32fba-503a-f5e5-e053-2a95a90a57e59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73635-7102-5736357102051 BOTTLE, WITH APPLICATOR in 1 BOX (73635-7102-5) / 14.8 mL in 1 BOTTLE, WITH APPLICATOR2019-03-290000-00-00NoNoCurrent