FDA.reportPublic FDA data

ProCure ClamaPlex

Product NDC
55681-044
11-digit product format
556810044
Labeler code
55681
Product ID
55681-044_3d366857-5179-9032-e063-6294a90a40f3
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide 20.625, Menthol 0.44, White Petrolatum 66.335
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Twin Med LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
WHITE PETROLATUM; ZINC OXIDE; MENTHOL
Active strength
66.335; 20.625; .44 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
ProCure ClamaPlex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WHITE PETROLATUM66.335 g/100g
ZINC OXIDE20.625 g/100g
MENTHOL.44 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B6E5W8RQJ4Internal UNII lookup
SOI2LOH54ZInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d366857-5178-9032-e063-6294a90a40f3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-044-04ProCure ClamaPlex113 g in 1 TUBEOINTMENT1131
55681-044-05ProCure ClamaPlex5 g in 1 PACKETOINTMENT51
55681-044-14ProCure ClamaPlex144 in 1 CARTONOINTMENT1441

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 17 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DCH Rapid Relief HemorrhoidalLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labs00eef84c-a72e-3343-e063-6294a90aa4d82024-12-19WarningsExact identifier
application number: M015
Formula 2 Skin CareLIDOCAINE 5%Derma Care Research Labsa05d5e07-ae4b-38cc-e053-2a95a90abced2024-12-19WarningsExact identifier
application number: M015
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
application number: M015
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELTrifecta Pharmaceuticals Usa Llc651c0143-384c-3649-e053-2991aa0a0f282024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
application number: M015
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal PadsWITCH HAZELDickinson Brands Inc.1b50f4dc-c26a-431a-ae18-c43513871b392024-12-18WarningsExact identifier
application number: M015
RECTICARELIDOCAINEFerndale Laboratories, Inc.49cb48cf-7a26-4d7a-887f-2e98261d269d2024-12-17WarningsExact identifier
application number: M015
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
application number: M015
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
application number: M015
PRAXPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.674f0d8b-3d50-42b1-8401-d2967bcdf5cf2024-12-17WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
application number: M015
Warrior Rectal CareLIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labsfc10cbc3-fc1b-ae09-e053-6394a90ac8f32024-12-15WarningsExact identifier
application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)GLYCERIN, LIDOCAINE, AND WITCH HAZELBlistex Inca7cb6d78-3048-43b3-afe7-4d862fdcfd3f2024-12-13WarningsExact identifier
application number: M015
Tucks Medicated Cooling PadsWITCH HAZELBlistex Incb3e68008-3d0d-4124-9579-b503e9fb95c92024-12-13WarningsExact identifier
application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.2a4273a4-3bda-4653-a065-cd4578053f3c2024-12-12WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELMedical Products Laboratories, Inc.b815792f-2f8f-7ac8-e053-2995a90ade182024-12-11WarningsExact identifier
application number: M015
ZensaLIDOCAINEAlera Skin Care Products Inc.f56146b6-3c11-4608-a6ab-6142f27e9ac32024-11-24WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55681-044-0455681004404113 g in 1 TUBE (55681-044-04) 113 g2025-12-01NoNoCurrent
55681-044-05556810044055 g in 1 PACKET5 gHistorical
55681-044-1455681004414144 PACKET in 1 CARTON (55681-044-14) / 5 g in 1 PACKET (55681-044-05) 144 packet2025-12-01NoNoCurrent