FDA.reportPublic FDA data

Atomic Balm

Product NDC
82345-856
11-digit product format
823450856
Labeler code
82345
Product ID
82345-856_097358e0-ead1-c991-e063-6294a90acb81
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE, CAPSAICIN
Dosage form
OINTMENT
Route
TOPICAL
Labeler
The Hygenic Company, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-01
Substance
METHYL SALICYLATE; CAPSAICIN
Active strength
125; .25 mg/g; mg/g
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
Atomic Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE125 mg/g
CAPSAICIN.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1923329Internal RxNorm lookup
2597539Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d10028f3-ae6a-7b01-e053-2995a90a5a84Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82345-856-01Atomic Balm454 g in 1 JAROINTMENT4542

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82345-856ATOMIC BALM (METHYL SALICYLATE, CAPSAICIN) OINTMENT [THE HYGENIC COMPANY, LLC]2Current NDC, Legacy NDC, 1 package rows20231106_d10028f3-ae6a-7b01-e053-2995a90a5a84.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 116 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care MentholMENTHOL 4%Safeway27d3cb47-a6c7-5b7a-e063-6394a90a056f2024-12-05WarningsExact identifier
application number: M017
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
application number: M017
PO First Aid Series BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.f1c349a8-216d-4233-922e-c95329a33d1e2024-12-05WarningsExact identifier
application number: M017
Post Treatment BalmHYDROCORTISONEAllure Labs Inc.faa803e6-453c-4d86-85dd-5a5dcdd72d022024-12-05WarningsExact identifier
application number: M017
CBD Pain Relief CreamTROLAMINE SALICYLATEAllure Labsb6b3102a-4154-2da2-e053-2995a90ae99f2024-12-05WarningsExact identifier
application number: M017
CVS Health Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATENatural Essentials, Inc.f7198485-3d68-41d2-b9b9-f932a06493102024-12-04WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
application number: M017
Bite and ItchDIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEWeeks & Leo Co., Inc.0a4d471b-c3f3-0a6a-e063-6394a90ad57b2024-12-03WarningsExact identifier
application number: M017
MentholAMISH ORIGINS MEDICATEDAmish Origins LLC547abe39-3af3-4d70-99dd-caf8d67feda22024-12-03WarningsExact identifier
application number: M017
Meijer Small Cold-Hot Medicated PatchesMENTHOLMeijer Distribution Incbe6012d6-2062-45ba-8fc4-abf14cff58452024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.acdd5622-a9a7-4cc3-877e-57efea23303f2024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff52024-12-03WarningsExact identifier
application number: M017
Salonpas DEEP RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu America, Inc.a4ddb2b9-d023-4c8c-9285-93d51f93207d2024-12-03WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief - OvernightLIDOCAINETelebrands Corp1030d478-6805-6579-e063-6294a90a0c762024-12-02WarningsExact identifier
application number: M017
Campho-Phenique Cold Sore TreatmentCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC106c0bb2-f2e2-4255-867d-d09ff6a5a2e62024-12-02WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC82edaef0-0709-4ae1-a664-c9c5adb91ee12024-12-02WarningsExact identifier
application number: M017
Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll OnTHERMACARE CAPSAICIN ROLL ONClarion Brands LLC2850f7e7-41dd-f5f9-e063-6394a90ae5192024-12-02WarningsExact identifier
application number: M017
BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENINGBO TIANBO FIRST AID PRODUCT CO., LTD.2ec1cf79-c341-4b79-9047-ce29f0dff4192024-11-29WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare242204d3-efc7-f7a9-e063-6294a90a5af12024-11-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2597539Atomic Balm 0.025 % / 12.5 % Topical OintmentPSNd10028f3-ae6a-7b01-e053-2995a90a5a842
1923329capsaicin 0.025 % / methyl salicylate 12.5 % Topical OintmentPSNd10028f3-ae6a-7b01-e053-2995a90a5a842
2597539capsaicin 0.00025 MG/MG / methyl salicylate 0.125 MG/MG Topical Ointment [Atomic Balm]SBDd10028f3-ae6a-7b01-e053-2995a90a5a842
1923329capsaicin 0.00025 MG/MG / methyl salicylate 0.125 MG/MG Topical OintmentSCDd10028f3-ae6a-7b01-e053-2995a90a5a842
2597539Atomic Balm (capsaicin 0.025 % / methyl salicylate 12.5 % ) Topical OintmentSYd10028f3-ae6a-7b01-e053-2995a90a5a842
1923329capsaicin 0.025 % / methyl salicylate 12.5 % Topical OintmentSYd10028f3-ae6a-7b01-e053-2995a90a5a842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82345-856-0182345085601454 g in 1 JAR (82345-856-01) 454 g2022-04-010000-00-00NoNoCurrent