oral pain relief gel

Generic: benzocaine 20%

Labeler: sled distribution, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name oral pain relief gel
Generic Name benzocaine 20%
Labeler sled distribution, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

benzocaine 200 mg/g

Manufacturer
Sled Distribution, LLC

Identifiers & Regulatory

Product NDC 81417-001
Product ID 81417-001_0f004372-e6f5-c2b0-e063-6394a90ad29c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2022-08-29

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81417001
Hyphenated Format 81417-001

Supplemental Identifiers

RxCUI
238910
UNII
U3RSY48JW5
NUI
N0000185508 N0000175629 N0000184306 M0000728

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name oral pain relief gel (source: ndc)
Generic Name benzocaine 20% (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
source: ndc
Packaging
  • .75 g in 1 POUCH (81417-001-01)
source: ndc

Packages (1)

81417-001-01 .75 g in 1 POUCH (81417-001-01)

Ingredients (1)

benzocaine (200 mg/g)

Linked Drug Pages (1)

Oral Pain Relief Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0f004372-e6f5-c2b0-e063-6394a90ad29c", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["238910"], "spl_set_id": ["e7391302-831e-14dc-e053-2a95a90ac236"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Sled Distribution, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": ".75 g in 1 POUCH (81417-001-01)", "package_ndc": "81417-001-01", "marketing_start_date": "20220829"}], "brand_name": "Oral Pain Relief Gel", "product_id": "81417-001_0f004372-e6f5-c2b0-e063-6394a90ad29c", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "81417-001", "generic_name": "Benzocaine 20%", "labeler_name": "Sled Distribution, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Oral Pain Relief Gel", "active_ingredients": [{"name": "BENZOCAINE", "strength": "200 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220829", "listing_expiration_date": "20261231"}