FDA.reportPublic FDA data

NECK AND LUMBAR PAIN RELIEVING BALM

Product NDC
55614-661
11-digit product format
556140661
Labeler code
55614
Product ID
55614-661_4346d79d-afac-5d30-e063-6394a90a3bcb
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL, METHYL SALICYLATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
MADISON ONE ACME INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-21
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
11; 16; 30 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
NECK AND LUMBAR PAIN RELIEVING BALM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)11 g/100g
MENTHOL16 g/100g
METHYL SALICYLATE30 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2370911Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d06f0650-a5f6-4bc1-a70b-b0fc16968fa9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55614-661-01NECK AND LUMBAR PAIN RELIEVING BALM80 g in 1 BOTTLE, GLASSOINTMENT803
55614-661-01NECK AND LUMBAR PAIN RELIEVING BALM1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55614-661NECK AND LUMBAR PAIN RELIEVING BALM (CAMPHOR, MENTHOL, METHYL SALICYLATE) OINTMENT [MADISON ONE ACME INC]2Current NDC, Legacy NDC, 2 package rows20241127_d06f0650-a5f6-4bc1-a70b-b0fc16968fa9.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 40 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relieving PatchLIDOCAINEFlexiGo Inc.4868af2a-c4be-9c68-e063-6394a90a565b2026-01-15WarningsExact identifier
application number: M017
Helocaine Cold Sore Fever Blister TreatmentTETRACAINE, MINERALPagari Life Science Corp.1b2eae09-5de0-9219-e063-6294a90af0462026-01-15WarningsExact identifier
application number: M017
Careland Lidocaine 4 Pain Relieving Gel-PatchesLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6ca8382-7ce5-4df9-912e-8a0ac04231162026-01-15WarningsExact identifier
application number: M017
Neuropathy CreamMENTHOL CREAMOwell Naturals Brand, LLC48739205-627b-41d0-e063-6394a90a34622026-01-15WarningsExact identifier
application number: M017
BLT 1BENZOCAINECENTURA PHARMACEUTICALS INC3eea2171-850b-4045-e054-00144ff8d46c2026-01-15WarningsExact identifier
application number: M017
Icy Hot Lidocaine DryLIDOCAINE, MENTHOLChattem, Inc.d500a74e-ab93-4919-8665-a89e9d4cad282026-01-15WarningsExact identifier
application number: M017
Cortizone 10 Bug Bite Relief1% HYDROCORTISONEChattem, Inc.b21b6c04-8246-4567-98cf-64e8c588e79c2026-01-15WarningsExact identifier
application number: M017
Gold Bond Intensive Relief Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLChattem, Inc.e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f82026-01-14WarningsExact identifier
application number: M017
Cortizone-10 Soothing Aloe CremeHYDROCORTISONEChattem, Inc.1a841bf0-9d7b-4566-b442-aa9bcc8278462026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Sensitive Skin CremeHYDROCORTISONEChattem, Inc.b139917c-00bb-4cb3-995d-a6d2f2c295c62026-01-14WarningsExact identifier
application number: M017
Cortizone 10 for PsoriasisHYDROCORTIZONEChattem, Inc.fad9eedb-95e1-4e1a-91e5-0bfd077e0cf52026-01-14WarningsExact identifier
application number: M017
Pain Relief Roll OnTOPICAL ANALGESICEagle Labs Inc2380a400-062a-4a8d-a594-a2e0972190442026-01-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINE 4%AvKARE70aace2f-47b4-e961-e053-2991aa0a63672026-01-14WarningsExact identifier
application number: M017
JUST CBD - ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLC485f355a-4458-67b6-e063-6394a90ab2a02026-01-14WarningsExact identifier
application number: M017
Relief Pain Relieving CreamMENTHOLCorganics, LP85814fff-35f8-447f-b669-87eaf55e98592026-01-14WarningsExact identifier
application number: M017
Mentholatum Soothing Vapor Rub CherryCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company486269c9-af3a-7856-e063-6294a90a378c2026-01-14WarningsExact identifier
application number: M017
Mentholatum Vapor MaxCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company4863606f-f7c8-b4a4-e063-6294a90a11382026-01-14WarningsExact identifier
application number: M017
Hydrocortisone Cream Intensive HealingHYDROCORTISONE CREAMWalgreens8a3f486c-1353-466d-9ea7-c14559b53bf32026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreense8f69c4b-2570-477e-9c6d-d552d30ac0d02026-01-14WarningsExact identifier
application number: M017
HydrocortisoneCOOL RELIEF GEL WITH ALOEWalgreens1ae2b37d-d5b2-74d2-e063-6294a90a0de02026-01-14WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2370911camphor 11 % / menthol 16 % / methyl salicylate 30 % Topical OintmentPSNd06f0650-a5f6-4bc1-a70b-b0fc16968fa93
2370911camphor 0.11 MG/MG / menthol 0.16 MG/MG / methyl salicylate 0.3 MG/MG Topical OintmentSCDd06f0650-a5f6-4bc1-a70b-b0fc16968fa93
2370911camphor 11 % / menthol 16 % / methyl salicylate 30 % Topical OintmentSYd06f0650-a5f6-4bc1-a70b-b0fc16968fa93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55614-661-01556140661011 BOTTLE, GLASS in 1 BOX (55614-661-01) / 80 g in 1 BOTTLE, GLASS2020-05-210000-00-00NoNoCurrent