FDA.reportPublic FDA data

Salinocaine

Product NDC
10733-415
11-digit product format
107330415
Labeler code
10733
Product ID
10733-415_1f19cc2c-57ab-4ad4-e063-6294a90a7613
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
salicylic acid and benzocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Medical Products Laboratories, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1938-06-01
Substance
BENZOCAINE; SALICYLIC ACID
Active strength
20; 550 mg/g; mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Salinocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 mg/g
SALICYLIC ACID550 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, O414PZ4LPZ
Rxcui1603377, 1603382

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10733-415-402020-11-25C16284748780-19d75b9d0-032e-f424-e053-dadaa90a57ceSALINOCAINE OINTMENT
10733-415-402020-01-31C16284748780-19d75b9d0-032e-f424-e053-dadaa90a57ceSALINOCAINE OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10733-415-40Salinocaine40 g in 1 JAROINTMENT409

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5SALINOCAINE (SALICYLIC ACID AND BENZOCAINE) OINTMENT [MEDICAL PRODUCTS LABORATORIES, INC.]4
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZSALINOCAINE (SALICYLIC ACID AND BENZOCAINE) OINTMENT [MEDICAL PRODUCTS LABORATORIES, INC.]4
BenzocaineACTIVE MOIETYU3RSY48JW5SALINOCAINE (SALICYLIC ACID AND BENZOCAINE) OINTMENT [MEDICAL PRODUCTS LABORATORIES, INC.]4
Salicylic AcidACTIVE MOIETYO414PZ4LPZSALINOCAINE (SALICYLIC ACID AND BENZOCAINE) OINTMENT [MEDICAL PRODUCTS LABORATORIES, INC.]4
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7SALINOCAINE (SALICYLIC ACID AND BENZOCAINE) OINTMENT [MEDICAL PRODUCTS LABORATORIES, INC.]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXSALINOCAINE (SALICYLIC ACID AND BENZOCAINE) OINTMENT [MEDICAL PRODUCTS LABORATORIES, INC.]4
PetrolatumINACTIVE INGREDIENT4T6H12BN9USALINOCAINE (SALICYLIC ACID AND BENZOCAINE) OINTMENT [MEDICAL PRODUCTS LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10733-415SALINOCAINE (SALICYLIC ACID AND BENZOCAINE) OINTMENT [MEDICAL PRODUCTS LABORATORIES, INC.]9Current NDC, Legacy NDC, 1 package rows20240809_49d9f83d-3055-f80e-e58a-b6fca192ac8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1603377salicylic acid 550 MG / benzocaine 20 MG per GM Topical OintmentPSN49d9f83d-3055-f80e-e58a-b6fca192ac8d9
1603382Salinocaine (salicylic acid 550 MG / benzocaine 20 MG) per GM Topical OintmentPSN49d9f83d-3055-f80e-e58a-b6fca192ac8d9
1603382benzocaine 0.02 MG/MG / salicylic acid 0.55 MG/MG Topical Ointment [Salinocaine]SBD49d9f83d-3055-f80e-e58a-b6fca192ac8d9
1603377benzocaine 0.02 MG/MG / salicylic acid 0.55 MG/MG Topical OintmentSCD49d9f83d-3055-f80e-e58a-b6fca192ac8d9
1603377benzocaine 2 % / salicylic acid 55 % Topical OintmentSY49d9f83d-3055-f80e-e58a-b6fca192ac8d9
1603382Salinocaine (benzocaine 2 % / salicylic acid 55 % ) Topical OintmentSY49d9f83d-3055-f80e-e58a-b6fca192ac8d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10733-415-401073304154040 g in 1 JAR (10733-415-40) 40 g1938-06-010000-00-00NoNoCurrent