FDA.reportPublic FDA data

4x Medicated Toothache and Gum Cream

Product NDC
0363-0607
11-digit product format
003630607
Labeler code
0363
Product ID
0363-0607_43956f7c-4305-e136-e063-6394a90a61d0
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
CREAM
Route
ORAL
Labeler
Walgreens
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-02
Substance
BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength
20; .13; .15; .26 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0363-0607UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-06070363-0607-79UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-06070363-0607-19UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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
4x Medicated Toothache and Gum Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g
BENZALKONIUM CHLORIDE.13 g/100g
ZINC CHLORIDE.15 g/100g
MENTHOL, UNSPECIFIED FORM.26 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
F5UM2KM3W7Internal UNII lookup
86Q357L16BInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2370903Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a71c2092-4ece-b82e-e053-2995a90ac933Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0607-194x Medicated Toothache and Gum Cream1 in 1 CARTONCREAM110
0363-0607-194x Medicated Toothache and Gum Cream14 g in 1 TUBECREAM1410
0363-0607-794x Medicated Toothache and Gum Cream1 in 1 CARTONCREAM110
0363-0607-794x Medicated Toothache and Gum Cream9.4 g in 1 TUBECREAM9.410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-06074X MEDICATED TOOTHACHE AND GUM CREAM (BENZOCAINE) CREAM [WALGREENS]8Current NDC, Legacy NDC, 4 package rows20250123_a71c2092-4ece-b82e-e053-2995a90ac933.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 46 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Lidocaine Pain ReliefLIDOCAINEVeridian Healthcareee8cd550-64ee-432e-98e5-b68083179a3c2026-01-05WarningsExact identifier
application number: M017
REGENECARE HALIDOCAINE HCLMPM Medical LLC0eee554f-dfe0-433a-9665-8bdb952298882026-01-05WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLPAIN WIZARD LIMITED LIABILITY COMPANY2647bba1-87f4-3c16-e063-6394a90ae0c92026-01-05WarningsExact identifier
application number: M017
TheraCare Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcareefddd116-d753-425a-9ded-09b8045024e42026-01-05WarningsExact identifier
application number: M017
TheraCare Original MentholMENTHOLVeridian Healthcareea56e4e1-a758-428b-8758-ee31bb00ca822026-01-05WarningsExact identifier
application number: M017
Mugwort Patch (Cervical spine use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e220c-0d35-9ee0-e063-6294a90ab6892026-01-04WarningsExact identifier
application number: M017
Mugwort Patch (Lumbar spine use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e4b21-6d81-4cd3-e063-6394a90a18fe2026-01-04WarningsExact identifier
application number: M017
Mugwort Patch (Knee use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e86d2-3030-91eb-e063-6394a90a4db02026-01-04WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inc4a543f90-d43c-4487-b27e-f43394c6320d2026-01-04WarningsExact identifier
application number: M017
Doctor Hoys Pain Relief GelMENTHOL, CAMPHOR (SYNTHETIC)Dynamic Blending Specialists, Inc.50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a82026-01-02WarningsExact identifier
application number: M017
Doctor Hoys Pain Relief Gel Roll-OnMENTHOL, CAMPHOR (SYNTHETIC)Dynamic Blending Specialists, Inc.bf47acb2-6c90-4d5c-820b-447cac9305a42026-01-02WarningsExact identifier
application number: M017
Amino Rip Muscle Pain ReliefLIDOCAINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2bed5764-4217-4aa3-9d90-3b5460dcffa32026-01-02WarningsExact identifier
application number: M017
Menthozen CreamMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC63bb0283-cfbe-4e9c-8772-73062c0c8d052026-01-01WarningsExact identifier
application number: M017
Menthozen HydrogelMENTHOL, CAPSAICINVillage Pharma LLC4c979a71-7c8f-4dff-abae-bf4cdf8f67b42026-01-01WarningsExact identifier
application number: M017
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma LLCffb7831f-4ca9-4d73-8303-e9cd900789822026-01-01WarningsExact identifier
application number: M017
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.116ee6dc-9c49-2e11-e063-6394a90a44ed2026-01-01WarningsExact identifier
application number: M017
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb132026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES5adf457e-b4d0-30c8-e063-6294a90a64b92026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES490bc3b1-48bf-5437-e063-6394a90a90182026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5ae00308-0a8c-065c-e063-6394a90aff6b2026-01-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamPSNa71c2092-4ece-b82e-e053-2995a90ac93310
2370903benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral CreamSCDa71c2092-4ece-b82e-e053-2995a90ac93310
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamSYa71c2092-4ece-b82e-e053-2995a90ac93310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0607-19003630607191 TUBE in 1 CARTON (0363-0607-19) / 14 g in 1 TUBE1 tube2024-02-16NoNoCurrent
0363-0607-79003630607791 TUBE in 1 CARTON (0363-0607-79) / 9.4 g in 1 TUBE1 tube2020-06-020000-00-00NoNoCurrent