Home NDC 55636-590 Promescent
Product NDC 55636-590
11-digit product format 556360590
Labeler code 55636
Product ID 55636-590_5578bdd9-b03b-b909-e063-6294a90a0c79
Type HUMAN OTC DRUG
Nonproprietary name Lidicaine
Dosage form SPRAY
Route TOPICAL
Labeler Absorption
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance LIDOCAINE
Active strength 10 g/100g
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 55636-590 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 55636-590 55636-590-74 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 55636-590 55636-590-13 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 Promescent
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 10 g/100g
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55636-590 PROMESCENT (LIDICAINE) SPRAY [ABSORPTION] 10 Current NDC, Legacy NDC, 6 package rows 20250504_5b508238-3be7-4b0d-bf35-51de79f58f55.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 18 of 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55636-590-13 55636059013 1 BOTTLE, SPRAY in 1 CARTON (55636-590-13) > 1.3 g in 1 BOTTLE, SPRAY 2013-01-11 0000-00-00 No No Current 55636-590-26 55636059026 1 BOTTLE, SPRAY in 1 CARTON (55636-590-26) / 2.6 g in 1 BOTTLE, SPRAY 2024-01-01 0000-00-00 No No Current 55636-590-52 55636059052 1 BOTTLE, SPRAY in 1 CARTON (55636-590-52) / 5.4 g in 1 BOTTLE, SPRAY 2024-01-01 0000-00-00 No No Current 55636-590-74 55636059074 1 BOTTLE, SPRAY in 1 CARTON (55636-590-74) / 7.4 g in 1 BOTTLE, SPRAY 2024-01-01 0000-00-00 No No Current