FDA.reportPublic FDA data

DG 4x Medicated Tooth and Gum Cream

Product NDC
55910-660
Requested package NDC
55910-660-09
11-digit product format
559100660
Labeler code
55910
Product ID
55910-660_441d3a38-e992-2d1d-e063-6394a90ae911
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
CREAM
Route
ORAL
Labeler
Dollar General
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-28
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL, UNSPECIFIED FORM; ZINC CHLORIDE
Active strength
.13; 20; .26; .15 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 · 1 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 packagepackage55910-66055910-660-09UExcluded 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
DG 4x Medicated Tooth and Gum Cream
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86Q357L16BInternal UNII lookup
F5UM2KM3W7Internal UNII lookup
L7T10EIP3AInternal UNII lookup
U3RSY48JW5Internal 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
b2c156f0-6d11-1eba-e053-2995a90a6db8Available 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
55910-660-09DG 4x Medicated Tooth and Gum Cream9.4 g in 1 TUBECREAM9.46
55910-660-09DG 4x Medicated Tooth and Gum Cream1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-660DG 4X MEDICATED TOOTH AND GUM CREAM (BENZOCAINE) CREAM [DOLLAR GENERAL]4Current NDC, Legacy NDC, 2 package rows20250413_b2c156f0-6d11-1eba-e053-2995a90a6db8.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 1 of 41 · 819 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CrystLCare Regeneration PlusPOTASSIUM NITRATE, SODIUM FLUORIDEGreenMark Biomedical Inc.4f86d0a0-d73e-5605-e063-6394a90adb382026-09-14WarningsExact identifier
application number: M022
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022

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 CreamPSNb2c156f0-6d11-1eba-e053-2995a90a6db86
2370903benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral CreamSCDb2c156f0-6d11-1eba-e053-2995a90a6db86
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamSYb2c156f0-6d11-1eba-e053-2995a90a6db86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-660-09559100660091 TUBE in 1 CARTON (55910-660-09) / 9.4 g in 1 TUBE1 tube2020-10-280000-00-00NoNoCurrent