rectasmoothe

Generic: lidocaine 5%

Labeler: leading pharma, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name rectasmoothe
Generic Name lidocaine 5%
Labeler leading pharma, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

lidocaine 5 g/100g

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-301
Product ID 69315-301_97a3ef32-4387-45ae-80b9-faceaf833a9c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part346
Listing Expiration 2026-12-31
Marketing Start 2011-04-01

Pharmacologic Class

Established (EPC)
amide local anesthetic [epc] antiarrhythmic [epc]
Chemical Structure
amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315301
Hyphenated Format 69315-301

Supplemental Identifiers

RxCUI
1366789
UPC
0369315301302
UNII
98PI200987
NUI
N0000175682 M0000897 N0000175426 N0000175976

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 rectasmoothe (source: ndc)
Generic Name lidocaine 5% (source: ndc)
Application Number part346 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (69315-301-30) / 30 g in 1 TUBE
source: ndc

Packages (1)

69315-301-30 1 TUBE in 1 CARTON (69315-301-30) / 30 g in 1 TUBE

Ingredients (1)

lidocaine (5 g/100g)

Linked Drug Pages (1)

RectaSmoothe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "97a3ef32-4387-45ae-80b9-faceaf833a9c", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0369315301302"], "unii": ["98PI200987"], "rxcui": ["1366789"], "spl_set_id": ["78120481-b780-4e41-885d-11e424d1f717"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69315-301-30)  / 30 g in 1 TUBE", "package_ndc": "69315-301-30", "marketing_start_date": "20160515"}], "brand_name": "RectaSmoothe", "product_id": "69315-301_97a3ef32-4387-45ae-80b9-faceaf833a9c", "dosage_form": "CREAM", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "69315-301", "generic_name": "Lidocaine 5%", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "RectaSmoothe", "active_ingredients": [{"name": "LIDOCAINE", "strength": "5 g/100g"}], "application_number": "part346", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20110401", "listing_expiration_date": "20261231"}