FDA.reportPublic FDA data

Bakers Best Maximum Strength Pain Relief

Manufacturer
Baker's Best Health Products, LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:03

Label at a glance#

ProductBakers Best Maximum Strength Pain Relief
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure7 sections

Dosage and administration

• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. • Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl (4.00%), Menthol (1.00%)

OTC - PURPOSE SECTION

Pain Reliever

Indications:

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings:

WARNINGS SECTION

For external use only. • Avoid contact with eyes. • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

Do not apply

OTC - DO NOT USE SECTION

  • to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. • Children under two-years of age: consult a physician.

Additional Information:

SPL UNCLASSIFIED SECTION

• Store at room temperature.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionize Water), Cetyl Alcohol, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Methyl Salicylate, Methylsulfonylmethane (MSM), PEG-8, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Triethanolamine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3Label4Label4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSN4
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD4
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76102-031-022023-01-31C16284748780-1f386c649-e0a9-0266-e053-dadaa90a7c1aBaker's Best Maximum Strength Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76102-031-02Bakers Best Maximum Strength Pain Relief56.7 g in 1 JARCREAM56.74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76102-031BAKERS BEST MAXIMUM STRENGTH PAIN RELIEF (LIDOCAINE HYDROCHLORIDE, MENTHOL) CREAM [BAKER'S BEST HEALTH PRODUCTS, LLC]4Current NDC, Legacy NDC, 1 package rows20231106_9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76102-03176102-031-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
EMU OIL344821WD61IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAURETH-7Z95S6G8201IACT
METHYL SALICYLATELAV5U5022YIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bakers Best Maximum Strength Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLBaker's Best Health Products, LLC9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d2023-11-06WarningsExact identifier
ndc (package): 76102-031-02
ndc (product): 76102-031
ndc11 (package): 76102003102
spl id: 0975bb48-2470-e8bd-e063-6394a90ae8d9
spl set id: 9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.