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 78 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF PATCHESLIDOCAINEAmerisource Bergen614f1e56-891f-4620-be10-0c075a1dbc3f2025-09-11WarningsExact identifier
application number: M017
Industrial Itch and Pain ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATER & R Lotion, Inc236415fc-f923-4a82-b54a-ecaf666dd2e02025-09-11WarningsExact identifier
application number: M017
Eco Lips Menthol Medicated Lip BalmMENTHOLEco Lips, Inc.fc4c25d6-6109-dfd8-e053-6394a90a4e912025-09-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Encube Ethicals, Inc.d6f5c0df-6262-4704-bb24-430f66bb2ca82025-09-09WarningsExact identifier
application number: M017
Blue-Emu Lidocaine Pain Relief CreamLIDOCAINE CREAM 4%Kingsway Pharmaceuticals dba NFI, LLC592811f2-e21c-6a58-e053-2991aa0a69a92025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation282ed5ef-8c2a-4092-9d99-1a7eee7a39e32025-09-09WarningsExact identifier
application number: M017
LubeLife Climax Control DelayBENZOCAINECC Wellness LLCe1a98e6d-0c24-75b8-e053-2a95a90ad1362025-09-09WarningsExact identifier
application number: M017
Blue-Emu Maximum Pain ReliefTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLCc863351a-951b-4f7c-a9c0-4289d702054a2025-09-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.02a65b25-78b2-4e29-9484-40e2228fb3842025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporatione90df2e5-2ef4-47dd-bd74-be9cea6d9d852025-09-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation69d6645e-db3c-4dc0-a9a5-e2bc963e2f282025-09-08WarningsExact identifier
application number: M017
SupreH Arnica Bruise CreamSUPREH ARNICA REMEDY PLUS BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3e41fc0e-54c3-2622-e063-6294a90a13c92025-09-07WarningsExact identifier
application number: M017
MentholMENTHOLFlexiGo Inc3607c326-6db0-a2cd-e063-6394a90a9eb62025-09-06WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYOTHERAPY MENTHOL CreamPAIN RELIEF CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e08cc87-2385-0838-e063-6394a90abf9b2025-09-05WarningsExact identifier
application number: M017
TIDL CLINICAL CRYOTHERAPY MENTHOL CreamCLINICAL CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e090b98-1db7-4174-e063-6394a90aa5392025-09-05WarningsExact identifier
application number: M017
ALCEMISTELIDOCAINE HCLPrice Team Ventures, LLC4383faaa-49cf-47b7-83a6-c2a94b6ff9b52025-09-05WarningsExact identifier
application number: M017
Lansinoh Pain RelievingLIDOCAINE HCLLansinoh Laboratories Incb7cf1fdb-946d-a4e8-e053-2995a90a26a82025-09-05WarningsExact identifier
application number: M017
Sumifun PLANTAR RELIEF ROLL -ON4% LIDOCAINE, 1% MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd3c9ee60b-548a-979f-e063-6394a90a70b02025-09-03WarningsExact identifier
application number: M017
Meijer Capsaicin Heat PatchCAPSAICINMeijer Distribution3c465557-0a4f-fb72-e063-6294a90a1ef22025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC Ventures Corp DBA Cryodermdd95c682-8ddf-43e7-a277-2fca6ec744cc2025-09-02WarningsExact 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