Home NDC 65197-815 Bactine Max Dry
Product NDC 65197-815
11-digit product format 651970815
Labeler code 65197
Product ID 65197-815_144bf707-6b26-4386-a0ba-0a4a3a797be9
Type HUMAN OTC DRUG
Nonproprietary name lidocaine hydrochloride
Dosage form SPRAY
Route TOPICAL
Labeler WellSpring Pharmaceutical Corporation
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-31
Substance LIDOCAINE HYDROCHLORIDE
Active strength 4 g/100g
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 Bactine Max Dry
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100g
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 1869797 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 65197-815-04 Bactine Max Dry 113 g in 1 CAN SPRAY 113 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-815 BACTINE MAX DRY (LIDOCAINE HYDROCHLORIDE) SPRAY [WELLSPRING PHARMACEUTICAL CORPORATION] 6 Current NDC, 1 package rows 20250110_466404cd-c46a-4944-b1ac-3b3b17f436a1.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 104 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nourishing Hand Sanitizer Limon ALCOHOL Noshinku d70fba7a-513f-0341-e053-2a95a90add86 2024-05-15 Warnings Exact identifier application number: M003 Nourishing Hand Sanitizer Vetiver ALCOHOL Noshinku d70fb84c-fdbc-6ba8-e053-2995a90ab529 2024-05-15 Warnings Exact identifier application number: M003 Safly BZK Antiseptic Towelette BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 5cd9043e-daf2-43eb-9568-54775fc4f84a 2024-05-15 Warnings Exact identifier application number: M003 Noshinku Bergamot Hand Sanitizer ALCOHOL Noshinku 53fea81e-4482-6fae-e054-00144ff8d46c 2024-05-14 Warnings Exact identifier application number: M003 Noshinku Eucalyptus Hand Sanitizer ALCOHOL Noshinku 9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c0 2024-05-14 Warnings Exact identifier application number: M003 Noshinku Lavender Hand Sanitizer ALCOHOL Noshinku a57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf 2024-05-14 Warnings Exact identifier application number: M003 LEADER 2% Mild Iodine Tincture IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID Cardinal Health, 110 dba Leader 7f810b92-60f6-2f72-e053-2991aa0ab973 2024-05-13 Warnings Exact identifier application number: M003 Leader Decolorized Iodine ALCOHOL LIQUID Cardinal Health, 110 dba Leader 822f6f28-956f-dd82-e053-2991aa0ae752 2024-05-13 Warnings Exact identifier application number: M003 Inverness Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a2995-334c-2e93-e063-6294a90aecf7 2024-05-09 Warnings Exact identifier application number: M003 Helzberg Diamonds Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a3776-0edd-26f3-e063-6294a90a740d 2024-05-09 Warnings Exact identifier application number: M003 Ulta Beauty Ear Care BENZALKONIUM CHLORIDE The Richline Group, Inc. 180a37f4-8718-3e40-e063-6294a90acaad 2024-05-09 Warnings Exact identifier application number: M003 Guardian Vaginal BENZALKONIUM CHLORIDE Eastern Century Pharmaceuticals 1605ba44-02b7-4c72-9fec-89a5aa962b44 2024-04-24 Warnings Exact identifier application number: M003 Inverness Hygienic Ear Care Antiseptic BENZALKONIUM CHLORIDE The Richline Group, Inc. 0ccd72e7-16a2-47c7-9ce6-dffb63a0344b 2024-04-18 Warnings Exact identifier application number: M003 Lovisa Piercing Care Solution BENZALKONIUM CHLORIDE The Richline Group, Inc. 74f46b81-cc5b-4e3f-a36e-0bd86d370c22 2024-04-18 Warnings Exact identifier application number: M003 CliniClean BZK Cleansing Contains Benzalkonium Chloride BENZALKONIUM CHLORIDE HR HealthCare b6916466-0931-408f-a430-0797a449c32e 2024-04-18 Warnings Exact identifier application number: M003 Handy Solutions First Aid Kit BENZALKONIUM CHLORIDE Navajo Manufacturing Company Inc. 130237ff-3db4-1288-e063-6394a90ab1af 2024-04-16 Warnings Exact identifier application number: M003 BZK BENZALKONIUM CHLORIDE Henry Schein Inc. ff877b63-fa58-4770-a882-694eda33203b 2024-04-02 Warnings Exact identifier application number: M003 First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE M-star (Hubei) Health&Care Products Co., Ltd. 8e1f35ff-d4e6-4940-ad8f-dce2b73e595d 2024-04-01 Warnings Exact identifier application number: M003 Antiseptic Towelette TOALLITAS ANTISEPTICAS BENZALKONIUM CHLORIDE M-star (Hubei) Health&Care Products Co., Ltd. b267e186-cf7a-458f-9c28-a48a8554af40 2024-04-01 Warnings Exact identifier application number: M003 Antiseptic Povidone Iodine Prep Pad POVIDONE-IODINE M-star (Hubei) Health&Care Products Co., Ltd. fc76c1f3-b48e-4276-890d-5b8e5a894e62 2024-04-01 Warnings Exact identifier application number: M003
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65197-815-04 65197081504 113 g in 1 CAN (65197-815-04) 113 g 2023-01-31 No No Current