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 141 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Anti-itchHYDROCORTISONERite Aid0c540422-1579-9217-e063-6294a90ad06a2023-12-12WarningsExact identifier
application number: M017
Anti-itch Paraben FreeHYDROCORTISONEWeeks & Leo Co., Inc.0c5419c5-0929-7ca6-e063-6294a90ac0a72023-12-12WarningsExact identifier
application number: M017
Rite Aid HydrocortisoneHYDROCORTISONE 1%Rite Aid0c580f96-7fe9-19df-e063-6394a90a5a222023-12-12WarningsExact identifier
application number: M017
Anti itchHYDROCORTISONEWeeks & Leo Co., Inc.0c58b750-d3a6-5ed1-e063-6294a90a43212023-12-12WarningsExact identifier
application number: M017
Greencaine BlastLIDOCAINEALMA Laboratories, Inc.031e0065-4c8a-43d8-bc69-3efa3c6c0ae32023-12-12WarningsExact identifier
application number: M017
Ageless Pain ReliefMETHYL SALICYLATE, MENTHOLIsagenix International, LLC3c7e493b-923d-44b1-9076-46c7894308d42023-12-12Warnings, Adverse reactionsExact identifier
application number: M017
CVS Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATECVS857af609-9dd7-a07a-e053-2991aa0ab6ba2023-12-11WarningsExact identifier
application number: M017
Rite Aid Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERite Aid0c4170dd-e1fa-d549-e063-6394a90a5c232023-12-11WarningsExact identifier
application number: M017
Westlake Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEWestlake HB Pharma LLC0c416ba6-b01f-0609-e063-6294a90ae2a12023-12-11WarningsExact identifier
application number: M017
CVS Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS87473ace-d834-e43f-e053-2a95a90a819c2023-12-11WarningsExact identifier
application number: M017
Katinko External Analgesic OilCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.5881fc35-3293-4f0b-801a-afcd6feb94962023-12-08WarningsExact identifier
application number: M017
Katinko Pain And Itch RelievingCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.fe907fa4-4a01-4974-b71f-9cd980b4eaa22023-12-08Warnings, Adverse reactionsExact identifier
application number: M017
CycleMENTHOLLa Mend, Inc.cfc0bcde-ef91-1e6c-e053-2a95a90ab79e2023-12-07WarningsExact identifier
application number: M017
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
application number: M017
Quatriderm Anti-itchHYDROCORTISONEOPMX LLC83e59e10-9878-e5c2-e053-2a91aa0af25e2023-12-04WarningsExact identifier
application number: M017
TACTDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLSato Pharmaceutical Inc., Ltd.b6e2ee24-69de-4dfd-9081-b9537b7a7bad2023-12-04WarningsExact identifier
application number: M017
Overnight Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.2cbd0966-4cf9-4271-bd53-6672b1ed2a992023-12-04WarningsExact identifier
application number: M017
Prolayed Lidocaine Male Genital DesensitizerLIDOCAINEViaDerma Distribution, Inc.9c5ad0d0-ca7a-4321-9334-f06f3f6be18f2023-12-02WarningsExact identifier
application number: M017
Liberdol Topical AnalgesicMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)ViaDerma Distribution, Incab52cd0e-34fa-41c7-9ce7-1183c2aff8d82023-12-01WarningsExact identifier
application number: M017
ProlayedLIDOCAINEMATRIX MIXOLOGY, INCae317876-adb1-6d13-e053-2995a90a74af2023-12-01WarningsExact 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