Home NDC 71927-012 American Safety First Aid
Product NDC 71927-012
11-digit product format 719270012
Labeler code 71927
Product ID 71927-012_5aebc911-05c4-d91c-e063-6294a90a8924
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine HCL
Dosage form SPRAY
Route TOPICAL
Labeler Orazen Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-03
Substance LIDOCAINE HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 American Safety First Aid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010769 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71927-012-01 American Safety First Aid 59.1 mL in 1 BOTTLE, SPRAY SPRAY 59.1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71927-012 AMERICAN SAFETY FIRST AID (LIDOCAINE HCL) SPRAY [ORAZEN INC] 2 Current NDC, Legacy NDC, 1 package rows 20240116_ea2f776b-dfd0-6ce4-e053-2995a90af009.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 109 of 151 · 3,020 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 71927-012-01 71927001201 59.1 mL in 1 BOTTLE, SPRAY (71927-012-01) 59.1 ml 2022-10-03 0000-00-00 No No Current