FDA.reportPublic FDA data

KEEPAN A

Product NDC
49873-019
11-digit product format
498730019
Labeler code
49873
Product ID
49873-019_2a7f0516-d3ad-54a9-e063-6394a90ad17c
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride, lidocaine hydrochloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1981-07-15
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
.1; 1 g/100mL; 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
KEEPAN A
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.1 g/100mL
LIDOCAINE HYDROCHLORIDE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246623Internal RxNorm lookup
1246628Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a30679d5-5507-499d-9d9f-498095fd32acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-019-01KEEPAN A60 mL in 1 BOTTLE, SPRAYSPRAY604
49873-019-01KEEPAN A1 in 1 CARTONSPRAY14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7KEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]1
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AKEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YKEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]1
LIDOCAINEACTIVE MOIETY98PI200987KEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MKEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KKEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RKEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-019KEEPAN A (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [SATO PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20250101_a30679d5-5507-499d-9d9f-498095fd32ac.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 114 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.5854f241-6cfc-4e5a-ba72-92dd0703f7282023-10-13WarningsExact identifier
application number: M003
DawnMist Alcohol Hand SanitizerALCOHOLDukal LLCa2df96a9-8514-6839-e053-2a95a90a94172023-10-13WarningsExact identifier
application number: M003
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
application number: M003
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDEAcme United Corporation07245b54-b193-178e-e063-6394a90a25812023-10-09WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLRejoice International Corp.06dc1730-216a-8b4d-e063-6294a90a41842023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dcf8dc-0831-475e-e063-6394a90a9fef2023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dd2427-097c-b0fa-e063-6294a90a4f822023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLRejoice International Corp.06da0cc1-95f2-4f88-e063-6394a90a25ea2023-10-03WarningsExact identifier
application number: M003
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite AidISOPROPYL ALCOHOLRite Aid Corporationaa0df5fe-62d1-407d-b8f9-a7fd9473d5692023-10-02WarningsExact identifier
application number: M003
Foaming Instant Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.5c1f69b7-c8d8-477c-b614-47a3287b0e4c2023-06-05WarningsExact identifier
application number: M003
Bactine Max DryLIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation466404cd-c46a-4944-b1ac-3b3b17f436a12022-12-27WarningsExact identifier
application number: M003
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
application number: M003
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
application number: M003
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
application number: M003
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
application number: M003
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246623benzalkonium chloride 0.1 % / lidocaine HCl 1 % Topical SprayPSNa30679d5-5507-499d-9d9f-498095fd32ac4
1246628KEEPAN A 0.1 % / 1 % Topical SprayPSNa30679d5-5507-499d-9d9f-498095fd32ac4
1246628benzalkonium chloride 1 MG/ML / lidocaine hydrochloride 10 MG/ML Topical Spray [Keepan]SBDa30679d5-5507-499d-9d9f-498095fd32ac4
1246623benzalkonium chloride 1 MG/ML / lidocaine hydrochloride 10 MG/ML Topical SpraySCDa30679d5-5507-499d-9d9f-498095fd32ac4
1246623benzalkonium chloride 0.1 % / lidocaine hydrochloride 1 % Topical SpraySYa30679d5-5507-499d-9d9f-498095fd32ac4
1246628Keepan A (benzlkonium chloride 0.1 % / lidocaine hydrochloride 1 % ) Topical SpraySYa30679d5-5507-499d-9d9f-498095fd32ac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49873-019-01498730019011 BOTTLE, SPRAY in 1 CARTON (49873-019-01) / 60 mL in 1 BOTTLE, SPRAY1981-07-150000-00-00NoNoCurrent