Home NDC 53997-001 Lansinoh Pain Relieving
Product NDC 53997-001
11-digit product format 539970001
Labeler code 53997
Product ID 53997-001_3e17a936-54d6-845f-e063-6394a90a9fc9
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine HCL
Dosage form SPRAY
Route TOPICAL
Labeler Lansinoh Laboratories Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-15
Substance LIDOCAINE
Active strength 4 g/100mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 Lansinoh Pain Relieving
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 4 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1869797 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53997-001-01 Lansinoh Pain Relieving 100 mL in 1 BOTTLE, PLASTIC SPRAY 100 8 53997-001-02 Lansinoh Pain Relieving 1 in 1 CARTON SPRAY 1 8
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 48 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53997-001-01 53997000101 100 mL in 1 BOTTLE, PLASTIC 100 ml Historical 53997-001-02 53997000102 1 BOTTLE, PLASTIC in 1 CARTON (53997-001-02) / 100 mL in 1 BOTTLE, PLASTIC (53997-001-01) 2021-02-15 0000-00-00 No No Current