FDA.reportPublic FDA data

Dermagesic

Product NDC
54859-202
11-digit product format
548590202
Labeler code
54859
Product ID
54859-202_47467902-6ca7-2b20-e063-6394a90aeff1
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine HCl, Zinc Oxide, Calamine
Dosage form
CREAM
Route
TOPICAL
Labeler
Llorens Pharmaceutical International Division
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-01
Substance
PRAMOXINE HYDROCHLORIDE; ZINC OXIDE; FERRIC OXIDE RED
Active strength
10; 4; 4 mg/g; mg/g; mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54859-202-04e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54859-202-049bebd1f3094a…5416666fcb17…

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
Dermagesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/g
ZINC OXIDE4 mg/g
FERRIC OXIDE RED4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
SOI2LOH54ZInternal UNII lookup
1K09F3G675Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1798481Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bbff6b53-29da-45c1-8ccd-3e9df7f250e0Available 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
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54859-202-042020-12-23C16284748780-19d75b9cf-e9ea-f424-e053-dadaa90a57ceDermagesic 202
54859-202-042020-01-31C16284748780-19d75b9cf-e9ea-f424-e053-dadaa90a57ceDermagesic 202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-202-04Dermagesic113 g in 1 JARCREAM1139

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-202DERMAGESIC (PRAMOXINE HCL, ZINC OXIDE, CALAMINE) CREAM [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]6Current NDC, Legacy NDC, 1 package rows20241222_bbff6b53-29da-45c1-8ccd-3e9df7f250e0.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 117 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Flexible Pain Relieving LidocaineLIDOCAINE, MENTHOLWalgreen Co.6f070fa3-a61a-4523-a470-ab58bf9400a32024-11-27WarningsExact identifier
application number: M017
Benadryl Original Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC920c50cb-9bdd-4a36-bb3d-c2559db733272024-11-26WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC884907a8-c884-4cce-ac10-9d4848fdba3e2024-11-22WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC7f067e95-e01c-4b9a-a02e-0af097beb18c2024-11-22WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC9ece9b3a-0092-4c1c-a913-c2fefcd705412024-11-22WarningsExact identifier
application number: M017
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1936c5f4-274b-8e49-e063-6394a90ac6422024-11-21WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief Cream Platinum 4% LidocaineLIDOCAINE 4%Telebrands Corp2788189e-35bc-d48c-e063-6294a90ae6c22024-11-21WarningsExact identifier
application number: M017
Family Wellness Ultra Strength Muscle RubULTRA STRENGTH MUSCLE RUBFAMILY DOLLAR (Family Wellness)554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a2024-11-21WarningsExact identifier
application number: M017
Family Wellness Anorectal LidocaineANORECTAL LIDOCAINEFAMILY DOLLAR (Family Wellness)ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d2024-11-21WarningsExact identifier
application number: M017
Family Wellness Hot and Cold Pain ReliefHOT AND COLD PAIN RELIEFFAMILY DOLLAR (Family Wellness)b70e343b-18aa-4e45-ae8e-79d8c84ad2052024-11-21WarningsExact identifier
application number: M017
Signature Care Lidocaine CreamLIDOCAINEBetter Living Brands LLC5483729e-ef1a-47a2-b7cf-c19744f520732024-11-21WarningsExact identifier
application number: M017
WINCO HydrocortisoneHYDROCORTISONE 1%WinCo Foods LLC26a29de3-4b79-4a3a-93b6-a14c5e91a8c62024-11-21WarningsExact identifier
application number: M017
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEDynarex Corporationd0e43651-4215-465b-9ace-1bc23126b1092024-11-20WarningsExact identifier
application number: M017
Hempvana Cold As Ice Pain Relief Gel-PatchMENTHOLTelebrands Corp976a1bb2-b776-8199-e053-2995a90a1a1b2024-11-20WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain ReliefTROLAMINE SALICYLATETELEBRANDS CORPd91a0fad-a38c-1580-e053-2a95a90ad2682024-11-20WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief - PlatinumTROLAMINE SALICYLATETELEBRANDS CORPd58da6c5-47a6-b8a8-e053-2995a90a7ce72024-11-20WarningsExact identifier
application number: M017
Hempvana Knee Bird Ultra Strength Pain ReliefLIDOCAINE, MENTHOLTELEBRANDS CORPdf5d3312-cbc5-5db9-e053-2995a90ab0552024-11-20WarningsExact identifier
application number: M017
Hempvana Cold as Ice GelMENTHOLTelebrands Corpa9e103f2-778f-e49b-e053-2a95a90aa8b72024-11-20WarningsExact identifier
application number: M017
Hempvana Knee Bird Ultra Strength Pain ReliefLIDOCAINE, MENTHOLTELEBRANDS CORPd58e2c47-c0f4-625e-e053-2a95a90aa4d52024-11-20WarningsExact identifier
application number: M017
Hempvana Pain ReliefTROLAMINE SALICYLATETelebrands Corp92a29553-a102-0a0e-e053-2a95a90ab24a2024-11-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798481pramoxine HCl 1 % / zinc oxide 0.4 % / calamine 0.4 % Topical CreamPSNbbff6b53-29da-45c1-8ccd-3e9df7f250e09
1798481calamine 4 MG/ML / pramoxine hydrochloride 10 MG/ML / zinc oxide 4 MG/ML Topical CreamSCDbbff6b53-29da-45c1-8ccd-3e9df7f250e09
1798481calamine 0.4 % / pramoxine HCl 1 % / zinc oxide 0.4 % Topical CreamSYbbff6b53-29da-45c1-8ccd-3e9df7f250e09
1798481Calamine 4 MG/ML / Pramoxine hydrochloride 10 MG/ML / ZNO 4 MG/ML Topical CreamSYbbff6b53-29da-45c1-8ccd-3e9df7f250e09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54859-202-0454859020204113 g in 1 JAR (54859-202-04) 113 g2016-04-010000-00-00NoNoCurrent