Home NDC 49314-0001 First Aid Antispetic
Product NDC 49314-0001
11-digit product format 493140001
Labeler code 49314
Product ID 49314-0001_3fe7ba5b-5fc3-c1b7-e063-6394a90a5b15
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form SPRAY
Route TOPICAL
Labeler Unishield
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-20
Substance BENZALKONIUM CHLORIDE
Active strength .13 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49314-0001-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49314-0001-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49314-0001-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49314-0001-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49314-0001-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49314-0001-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49314-0001-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49314-0001-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 First Aid Antispetic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49314-0001-1 First Aid Antispetic 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 49314-0001 FIRST AID ANTISPETIC (BENZALKONIUM CHLORIDE) SPRAY [UNISHIELD] 1 Current NDC, 1 package rows 20230320_f72851ba-bbdd-5533-e053-6294a90a8216.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 48 of 49 · 969 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Signature Black Bottle Tea Tree Antifungal Foot and Body Wash TOLNAFTATE Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) 2c966d97-30f5-4942-b64d-742884ce6a2f 2023-11-10 Warnings Exact identifier application number: M005 Smooth Gator Fungus Eliminator CLOTRIMAZOLE Smooth Gator, LLC 262b04f5-1b5d-4c67-a557-01f8b1711302 2023-11-10 Warnings Exact identifier application number: M005 TOLNAFTATE ANTIFUNGAL TOLNAFTATE Geri-Care Pharmaceuticals, Corp f9e60430-eec1-4bc2-9522-eb5aa527d90a 2023-11-08 Warnings Exact identifier application number: M005 Terrasil Jock Itch Treatment Maximum Strength CLOTRIMAZOLE Aidance Skincare & Topical Solutions, LLC c62fbf23-5d19-44ab-9c1a-e9b803192ed0 2023-11-08 Warnings Exact identifier application number: M005 terrasil The Fungal Solution Kit CLOTRIMAZOLE Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 9a5eb581-62a2-41fe-a174-e852fc47e235 2023-11-08 Warnings Exact identifier application number: M005 EmoniNail Antifungal UNDECYLENIC ACID GG Healthworks Inc. 84ace47a-d3ae-4735-87b6-dbbf1c40cf54 2023-11-06 Warnings Exact identifier application number: M005 CIDACIN Antifungal Treatment TOLNAFTATE Pedicis Research LLC bd53a9e3-65c8-4834-8e23-a2a928b83a66 2023-11-05 Warnings Exact identifier application number: M005 MacerRx Web MICONAZOLE NITRATE Clinical Therapeutic Solutions c9327f41-10f1-41f3-855b-838c701d6767 2023-11-05 Warnings Exact identifier application number: M005 CLARUS Antifungal TOLNAFTATE Clinical Therapeutic Solutions 7e8897ff-67d1-4336-866e-cb76a36edddc 2023-11-05 Warnings Exact identifier application number: M005 CLARUS Antifungal TOLNAFTATE Clinical Therapeutic Solutions 308a91d1-3511-4e2d-a62f-a31d77d70e06 2023-11-05 Warnings Exact identifier application number: M005 Human Science Antifungal Foot Care UNDECYLENIC ACID HUMAN SCIENCE, LLC 26b2519b-7d7b-4b33-b5d6-a41fe6f73538 2023-11-05 Warnings Exact identifier application number: M005 HomeHealth Antifungal TOLNAFTATE Home Health 895cd24c-3f78-4e2e-bf98-8bb6605798da 2023-11-05 Warnings Exact identifier application number: M005 Clotrimazole CLOTRIMAZOLE Proficient Rx LP 800a9dab-d287-427e-af6d-26996e0def41 2023-11-01 Warnings Exact identifier application number: M005 Povidone Iodine POVIDONE-IODINE Dr Radows 58e1757c-45ce-455e-bd64-a9e99cd3680f 2023-10-30 Warnings Exact identifier application number: M005 JOCK-EZE CLOTRIMAZOLE Bentlin Products LLC d3ff5bfb-2e0f-4daa-84b3-4a3016ca9280 2023-10-30 Warnings Exact identifier application number: M005 TheraPlus Plus CLOTRIMAZOLE Zhejiang Jingwei Pharmaceutical Co., Ltd. de75179d-1889-4823-9f39-4bebdf185d76 2023-10-27 Warnings Exact identifier application number: M005 Evercare Antifungal Treatment Super Absorbent Powder MICONAZOLE NITRATE PANEFFORT, LLC f91910f3-b461-43a4-9120-fda69483fffa 2023-10-26 Warnings Exact identifier application number: M005 Thera plus Antifungal Clotrimazole CLOTRIMAZOLE FOURSTAR GROUP USA, INC. 1265be99-8922-4b76-bd63-19bfb42c3896 2023-10-26 Warnings Exact identifier application number: M005 Thera plus Antifungal Tolnaftate TOLNAFTATE FOURSTAR GROUP USA, INC. c628dda8-7a6d-5f3a-e053-2995a90a35f8 2023-10-26 Warnings Exact identifier application number: M005 Povidone Iodine POVIDONE IODINE Jianerkang Medical Co., Ltd e1789944-3a41-4c86-b173-3a6993ae2141 2023-10-23 Warnings Exact identifier application number: M005
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49314-0001-1 49314000101 59.1 mL in 1 BOTTLE, SPRAY (49314-0001-1) 59.1 ml 2023-03-20 No No Current