TopCare Everyday After Sun Cooling

Product NDC
36800-953
11-digit product format
368000953
Labeler code
36800
Product ID
36800-953_24882cf3-66aa-4a61-e063-6394a90a63b5
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
TOPCO ASSOCIATES LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-05
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
5 mg/g
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
TopCare Everyday After Sun Cooling
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1011849Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
baff7293-e1a3-d1f2-e053-2995a90a93caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-953-80TopCare Everyday After Sun Cooling226 g in 1 BOTTLEGEL2262

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-953TOPCARE EVERYDAY AFTER SUN COOLING (LIDOCAINE HYDROCHLORIDE) GEL [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 1 package rows20241017_baff7293-e1a3-d1f2-e053-2995a90a93ca.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 113 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VAGISIL Anti-Itch Medicated Wipes Maximum StrengthPRAMOXINE HYDROCHLORIDECombe Incorporatedb848f53d-8aea-4efe-aa2c-009d5121fc332024-12-12WarningsExact identifier
application number: M017
Walgreens Cool and HeatMENTHOL 16%Walgreensce1585f4-ca65-8d0c-e053-2995a90a8e892024-12-11WarningsExact identifier
application number: M017
Walgreens Cool n HeatLIDOCAINE 4%Walgreensce1b21d6-7aa6-2b18-e053-2995a90a4c912024-12-11WarningsExact identifier
application number: M017
Walgreens Pain Burn Itch ReliefBENZOCAINE 20%, MENTHOL 0.5%Walgreenscc6e4b42-fdd8-6ff7-e053-2995a90a3d1d2024-12-11WarningsExact identifier
application number: M017
Pramoxine Itch reliefPRAMOXINE HCL 1%CVSe947694c-c122-0291-e053-2995a90ac39a2024-12-11WarningsExact identifier
application number: M017
Arthritis CreamTROLAMINE SALICYLATE 10%CVSd1663f50-479b-4d55-e053-2995a90a223f2024-12-11WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOL 4%CVSd1660d55-1ee0-7aa2-e053-2995a90a65792024-12-11WarningsExact identifier
application number: M017
CVS Muscle RubMENTHOL 10%, METHYL SALICYLATE 15%CVS Healthc72c9a95-4226-6d69-e053-2a95a90a8e1c2024-12-11WarningsExact identifier
application number: M017
BENGAY ULTRA STRENGTH NON-GREASYCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEKenvue Brands LLC0a41ec65-bd0b-4fc6-807d-74f353341cc72024-12-11WarningsExact identifier
application number: M017
Serum XLIDOCAINE HYDROCHLORIDEAO Biologix, LLCe07b6268-6400-6849-e053-2a95a90a8b3e2024-12-11WarningsExact identifier
application number: M017
PlusCBD Pain Cream (Penetrating) 2ozCAMPHOR, MENTHOLCV Sciences, Inc.ca39d327-6bf3-3408-e053-2a95a90af2d52024-12-11WarningsExact identifier
application number: M017
Blistex MedicatedDIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOLBlistex Inc.e95439d3-f12b-4c1c-999a-79f2ddba4cfb2024-12-11WarningsExact identifier
application number: M017
Blistex Foille Medicated First AidBENZOCAINE AND CHLOROXYLENOLBlistex Inc.e2eca808-e97b-43e0-aa51-7025cc61c7a82024-12-11WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEJ&A Digital Inc.ff95a536-35b3-4006-b43c-cce359e86aa92024-12-10WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEAlexso, Inceef555d3-f23d-4847-93f3-fa7a06072a0f2024-12-09WarningsExact identifier
application number: M017
Lidocaine 4 PercentLIDOCAINESA3, LLC651710db-3c50-4bcf-b7cc-9ed24f6634272024-12-09WarningsExact identifier
application number: M017
HealthWise Pain Relief Lidocaine PatchLIDOCAINE 4%Veridian Healthcare28db1c03-d01f-83ea-e063-6294a90aee262024-12-09WarningsExact identifier
application number: M017
Joint and Muscle Pain ReliefMENTHOLAllure Labse82f99fd-c2ef-686f-e053-2a95a90a1dc92024-12-09WarningsExact identifier
application number: M017
Tough Love Pain RelievingLIDOCAINE HCLAllure Labsee8c1a2b-36ef-6fd7-e053-2a95a90a9c012024-12-09WarningsExact identifier
application number: M017
CapsaicinCAPSAICINSA3, LLC5617e91d-e650-4a0d-8565-b8288ea41c772024-12-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011849lidocaine HCl 0.5 % Topical GelPSNbaff7293-e1a3-d1f2-e053-2995a90a93ca2
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCDbaff7293-e1a3-d1f2-e053-2995a90a93ca2
1011849lidocaine hydrochloride 0.5 % Topical GelSYbaff7293-e1a3-d1f2-e053-2995a90a93ca2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-953-8036800095380226 g in 1 BOTTLE (36800-953-80) 226 g2018-12-050000-00-00NoNoCurrent