FDA.reportPublic FDA data

Medline

Product NDC
53329-156
11-digit product format
533290156
Labeler code
53329
Product ID
53329-156_4161a6b2-cc86-f208-e063-6294a90ad120
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, white petrolatum, zinc oxide
Dosage form
PASTE
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-01
Substance
ZINC OXIDE; MENTHOL; PETROLATUM
Active strength
206; 4.4; 530 mg/g; 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
Medline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE206 mg/g
MENTHOL4.4 mg/g
PETROLATUM530 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
L7T10EIP3AInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2642278Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
006539c9-1982-d6de-e063-6294a90a1a5aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-156-14Medline57 g in 1 TUBEPASTE573
53329-156-44Medline113 g in 1 TUBEPASTE1133
53329-156-83Medline4 g in 1 PACKETPASTE43
53329-156-96Medline144 in 1 BOXPASTE1443
53329-156-83Clobezin4 g in 1 PACKETPASTE120 g4.4 mg in 1g2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-156-44GM - Gram53329-15661d08dbd-d8c2-495d-bcab-f4cf9e0b273d12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-156MEDLINE (MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP]2Current NDC, 4 package rows20240130_006539c9-1982-d6de-e063-6294a90a1a5a.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2642278menthol 0.44 % / petrolatum 53 % / zinc oxide 20.6 % Topical PastePSN006539c9-1982-d6de-e063-6294a90a1a5a3
2642278menthol 0.0044 MG/MG / petrolatum 0.53 MG/MG / zinc oxide 0.206 MG/MG PasteSCD006539c9-1982-d6de-e063-6294a90a1a5a3
2642278menthol 0.0044 MG/MG / petrolatum 0.53 MG/MG / ZNO 0.206 MG/MG PasteSY006539c9-1982-d6de-e063-6294a90a1a5a3
2642278menthol 0.44 % / petrolatum 53 % / zinc oxide 20.6 % Topical PasteSY006539c9-1982-d6de-e063-6294a90a1a5a3
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN94bab0bd-c0b7-42f5-9e3c-911408817aed2
2642278menthol 0.44 % / petrolatum 53 % / zinc oxide 20.6 % Topical PastePSN94bab0bd-c0b7-42f5-9e3c-911408817aed2
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD94bab0bd-c0b7-42f5-9e3c-911408817aed2
2642278menthol 0.0044 MG/MG / petrolatum 0.53 MG/MG / zinc oxide 0.206 MG/MG PasteSCD94bab0bd-c0b7-42f5-9e3c-911408817aed2
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY94bab0bd-c0b7-42f5-9e3c-911408817aed2
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY94bab0bd-c0b7-42f5-9e3c-911408817aed2
2642278menthol 0.0044 MG/MG / petrolatum 0.53 MG/MG / ZNO 0.206 MG/MG PasteSY94bab0bd-c0b7-42f5-9e3c-911408817aed2
2642278menthol 0.44 % / petrolatum 53 % / zinc oxide 20.6 % Topical PasteSY94bab0bd-c0b7-42f5-9e3c-911408817aed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-156-145332901561457 g in 1 TUBE (53329-156-14) 57 g2024-01-01NoNoCurrent
53329-156-4453329015644113 g in 1 TUBE (53329-156-44) 113 g2024-01-01NoNoCurrent
53329-156-83533290156834 g in 1 PACKET (53329-156-83) 4 g2023-04-01NoNoCurrent
53329-156-9653329015696144 PACKET in 1 BOX (53329-156-96) / 4 g in 1 PACKET (53329-156-83) 144 packet2023-04-01NoNoCurrent