FDA.reportPublic FDA data

4x Medicated Severe Toothache and Gum Gel

Product NDC
79481-0610
11-digit product format
794810610
Labeler code
79481
Product ID
79481-0610_437fd357-4fcb-b91b-e063-6394a90a2f3e
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
GEL
Route
ORAL
Labeler
Meijer
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-20
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE; ZINC CHLORIDE; MENTHOL
Active strength
.13; 20; .15; .5 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 · 2 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 productproduct79481-0610UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage79481-061079481-0610-9UExcluded 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 Severe Toothache and Gum Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g
BENZOCAINE20 g/100g
ZINC CHLORIDE.15 g/100g
MENTHOL.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
U3RSY48JW5Internal 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
2369638Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
97ce7890-5093-1763-e053-2a95a90afae7Available 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
79481-0610-94x Medicated Severe Toothache and Gum Gel7 g in 1 TUBEGEL75
79481-0610-94x Medicated Severe Toothache and Gum Gel1 in 1 CARTONGEL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-06104X MEDICATED SEVERE TOOTHACHE AND GUM GEL (BENZALKONIUM CHLORIDE) GEL [MEIJER]3Current NDC, 2 package rows20250119_97ce7890-5093-1763-e053-2a95a90afae7.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 125 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI070000d7-7d4d-439b-9a91-851ba7c027e62024-10-03WarningsExact identifier
application number: M017
hydrocortisone anti itchHYDROCORTISONEH E Ba1a9fed8-4938-48b5-81f1-d3942d534bb82024-10-03WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFIef9ea069-9b97-4bf5-aaac-deb85334dbd02024-10-03WarningsExact identifier
application number: M017
Basic Care HydrocortisoneHYDROCORTISONEAmazon.com Services LLC7fa13ab4-5f2d-4a48-816f-1b22d5f757b22024-10-03WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEA-S Medication Solutionsdc388dc1-0c4f-4bf1-8a12-fa39892317bc2024-10-02WarningsExact identifier
application number: M017
Geliga MuscularMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAfb2beb08-0ad6-a89d-e053-6294a90aa6fe2024-10-02WarningsExact identifier
application number: M017
Geliga Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAda28097f-4b5c-6159-e053-2a95a90a7d962024-10-02WarningsExact identifier
application number: M017
CircatrixCAPSAICINPureTek Corporationcd3b1256-2df8-dc26-e053-2a95a90ad0492024-10-02WarningsExact identifier
application number: M017
DermacinRx Penetral CreamCAPSAICINPureTek Corporation1e343a52-6071-3230-e054-00144ff8d46c2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEBorden Company (Private) Limited36abfc2c-d424-4df8-968d-866342c96a562024-10-02WarningsExact identifier
application number: M017
Eagle BalmCAMPHOR MENTHOLEagle Indo Pharma, PT87614869-9675-2c76-e053-2a95a90a48a92024-10-02WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedd9a93daa-4e24-6690-e053-2a95a90a147c2024-10-02WarningsExact identifier
application number: M017
Eagle Extra StrengthMENTHOL METHYL SALICYLATEBorden Company (Private) Limited5e02fbe3-5bc7-430e-b661-3a760ddd8fe02024-10-02WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEBorden Company (Private) Limitedc62a4313-2c07-5f58-e053-2995a90a083a2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEEagle Indo Pharma, PTe272ec90-3cd9-5b70-e053-2a95a90a1df42024-10-02WarningsExact identifier
application number: M017
RUGBY HYDROCORTISONE WITH ALOEHYDROCORTISONEA-S Medication Solutionsb2674075-aaa4-4c77-bcaa-a76336b3c3212024-10-02WarningsExact identifier
application number: M017
Herb Street Anti-Itch StickHYDROCORTISONEBalassa Laboratories Inc.8717faae-59c3-4c6f-9ef1-285c0d2445ed2024-10-01WarningsExact identifier
application number: M017
Herb Street Backache and Sore Muscle ReliefMENTHOLBalassa Laboratories Inc.aeac1b64-8689-4b3d-a41c-db41061257b52024-10-01WarningsExact identifier
application number: M017
Herb Street Arthritis ReliefMENTHOL/CAMPHORBalassa Laboratories Inc.a9d8ceb7-def0-415f-8fc1-ff8dd3e418552024-10-01WarningsExact identifier
application number: M017
Lido King Lidocaine 4% Pain Relieving Gel-PatchLIDOCAINEGalaxy Bio, Inc.2243734a-4ea2-a5e5-e063-6294a90aba152024-10-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369638benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral GelPSN97ce7890-5093-1763-e053-2a95a90afae75
2369638benzalkonium chloride 0.0013 MG/MG / benzocaine 0.2 MG/MG / menthol 0.005 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCD97ce7890-5093-1763-e053-2a95a90afae75
2369638benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral GelSY97ce7890-5093-1763-e053-2a95a90afae75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-0610-9794810610091 TUBE in 1 CARTON (79481-0610-9) / 7 g in 1 TUBE1 tube2019-11-20NoNoCurrent