FDA.reportPublic FDA data

Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION

Product NDC
83004-044
Requested package NDC
83004-044-01
11-digit product format
830040044
Labeler code
83004
Product ID
83004-044_54eb672b-d173-8cf6-e063-6394a90a436e
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL,PRAMOXINE HYDROCHLORIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rida LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-12
Substance
MENTHOL; PRAMOXINE HYDROCHLORIDE
Active strength
1; 10 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2745581Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b62d09e4-7ced-49a9-8c83-3a8ef580f25aAvailable on FDA.report

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 139 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINProficient Rx LP7e765fc1-74c6-4af3-a9cf-05b57011d7d82024-01-01WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Incc6a0880e-fc16-46e9-8314-c56c9d15bf312023-12-31WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Anti ItchHYDROCORTISONEL'Oreal USA Products Inc.8d65e945-2557-486f-9279-ecbaa08f31c42023-12-31WarningsExact identifier
application number: M017
Nighttime Sleep-Aid Non-Habit FormingDIPHENHYDRAMINE HCIAptaPharma Inc.ed0ba7aa-e794-43da-b576-6b9945bf74772023-12-30WarningsExact identifier
application number: M017
Sting-KillBENZOCAINE AND MENTHOLRANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTHb8bd9280-f20a-4b2a-aef7-a0ba7b3b87012023-12-29WarningsExact identifier
application number: M017
Maybelline New York Baby Lips Dr Rescue Medicated BalmMENTHOLL'Oreal USA Products Inc2f7b8221-66f6-4aed-8359-318cfc656a722023-12-28WarningsExact identifier
application number: M017
Equate CortisoneHYDROCORTISONE 1%Walmart Inc027fae33-93a0-a61f-e063-6294a90a990f2023-12-27WarningsExact identifier
application number: M017
Walgreens Cool n Heat LidocaineLIDOCAINE HCL 4%Walgreens Co0681c6c5-5a8b-ea9e-e063-6394a90a83bc2023-12-27WarningsExact identifier
application number: M017
EXTRA STRENGTH WAL-DRYL ITCH RELIEFDIPHENHYDRAMINE, ZINC ACETATEWALGREEN CO681cf1af-2cc3-4e6d-b76f-f00731ea3e122023-12-27WarningsExact identifier
application number: M017
XRay Pain ReliefMENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATEGenomma Lab USA5244ddee-fd9e-4df3-8fb3-b16aa321a3162023-12-27WarningsExact identifier
application number: M017
Camphor SpiritCAMPHOR 10%Pharma Nobis, LLCe42fbe63-b01c-4f85-e053-2a95a90a51432023-12-26WarningsExact identifier
application number: M017
Equate CalasprayPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Walmart Inc027ed5ab-05ec-569f-e063-6394a90abbc32023-12-26WarningsExact identifier
application number: M017
EXTERNAL ANALGESICCAMPHOR, CAPSICUM, MENTHOLHmong 213b6155a5-51aa-2780-e054-00144ff8d46c2023-12-26WarningsExact identifier
application number: M017
LEADER Camphor SpiritCAMPHOR (NATURAL)Cardinal Health, 110 dba Leader7d3b0b28-5190-0622-e053-2991aa0af5612023-12-22WarningsExact identifier
application number: M017
Antiseptic Instant Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharma Nobis, LLCe42f484d-a642-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Itch Relief GelITCH RELIEF GELPharma Nobis, LLCe42f484d-a641-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Witch HazelWITCH HAZELPharma Nobis, LLCe42f484d-a644-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Dermoplast Pain relievingBENZOCAINE, MENTHOLAdvantice Healthdad00c95-4e11-3eec-e053-2a95a90a7a182023-12-21WarningsExact identifier
application number: M017
equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesicLIDOCAINE HYDROCHLORIDEWal-Mart Stores, Inc.bf954949-a7b7-44ba-8565-f1d5c0a6c0d12023-12-21WarningsExact identifier
application number: M017
Bactine Max BandageLIDOCAINEWellSpring Pharmaceutical Corporation465dc46e-6435-4569-9516-f648d0fe0f092023-12-21WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-044-01830040044011 TUBE in 1 CARTON (83004-044-01) / 56 g in 1 TUBE1 tube2024-12-12NoNoCurrent