FDA.reportPublic FDA data

Roman Swipes

Product NDC
72484-433
11-digit product format
724840433
Labeler code
72484
Product ID
72484-433_2df3ab8d-6918-a250-e063-6294a90a64f9
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
TOPICAL
Labeler
Roman Health Ventures Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-10
Substance
BENZOCAINE
Active strength
4 g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72484-43372484-433-02DDiscontinued by firm2026-10-12
excluded packagepackage72484-43372484-433-03DDiscontinued by firm2026-10-12

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 · 14 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0572484-433-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0572484-433-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2672484-433-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2672484-433-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3172484-433-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2872484-433-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2172484-433-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1072484-433-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3172484-433-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2072484-433-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1072484-433-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0872484-433-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0372484-433-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0972484-433-03557ba5c1ecfa…9c80585c8c6e…

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
Roman Swipes
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7f0eac8c-7235-99d8-e053-2a91aa0a634eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72484-433-02Roman Swipes2 in 1 BOXLIQUID28
72484-433-02Roman Swipes1.2 mL in 1 PACKETLIQUID1.28
72484-433-03Roman Swipes3 in 1 BOXLIQUID38
72484-433-03Roman Swipes1.2 mL in 1 PACKETLIQUID1.28
72484-433-05Roman Swipes5 in 1 BOXLIQUID58
72484-433-05Roman Swipes1.2 mL in 1 PACKETLIQUID1.28
72484-433-08Roman Swipes8 in 1 BOXLIQUID88
72484-433-08Roman Swipes1.2 mL in 1 PACKETLIQUID1.28
72484-433-12Roman Swipes12 in 1 BOXLIQUID128
72484-433-12Roman Swipes1.2 mL in 1 PACKETLIQUID1.28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72484-433ROMAN SWIPES (BENZOCAINE) LIQUID [ROMAN HEALTH VENTURES INC.]8Current NDC, Legacy NDC, 10 package rows20250504_7f0eac8c-7235-99d8-e053-2a91aa0a634e.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 5 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RELIBONEOintmentTOPICAL ANALGESICOINTMENTGuangdong Jiaoyu Biotechnology Co., Ltd58ddaaf6-18ec-8c5b-e063-6294a90a28282026-08-12WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58de3a29-2bec-6e44-e063-6394a90a9c1a2026-08-12WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsExact identifier
application number: M017
Muscle Rub CreamMUSCLE RUBALLIED TRADE LINK LLC11d33e60-8c64-4316-a29a-d17e3e6e4a282026-08-11WarningsExact identifier
application number: M017
Gee GasonMALE GENITAL DESENSITIZERMon Gars Boutique Inc58c75e5c-b801-017f-e063-6394a90a1c752026-08-11WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58c84330-15bf-c397-e063-6394a90aba052026-08-11WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy0e988da1-1904-431d-a152-bdb2aacc8e162026-08-11WarningsExact identifier
application number: M017
Medicated BODYMENTHOLCVS Pharmacy, Inc.a0f61498-69c8-4ce0-bbd7-3a807f192d362026-08-11WarningsExact identifier
application number: M017
Muscle MoveMENTHOLSaje Natural Wellness Inc.526d3305-4cf8-2fc5-e063-6394a90ad53b2026-08-10WarningsExact identifier
application number: M017
Relieve and Relax Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLMAC Innovations, LLCc0528c36-d322-8110-e053-2995a90add6c2026-08-08WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsExact identifier
application number: M017
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
application number: M017
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy46921bea-fcbe-94d6-e063-6394a90a726b2026-08-07WarningsExact identifier
application number: M017
CVS Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Pharmacy524605f9-8b04-b600-e063-6394a90a4a022026-08-07WarningsExact identifier
application number: M017
LidonexLIDOCAINE HCL, MENTHOLAldama Pharmaceuticals, Inc365cf19c-70e0-c4e9-e063-6294a90ac4282026-08-07WarningsExact identifier
application number: M017
Blaster Pain Relief StickMENTHOL, METHYL SALICYLATE, CAMPHORKalahari Rose, LLC587d660a-5f80-de5a-e063-6394a90aa2872026-08-07WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72484-433-02724840433022 PACKET in 1 BOX (72484-433-02) > 1.2 mL in 1 PACKET2 packet2020-12-170000-00-00NoNoCurrent
72484-433-03724840433033 PACKET in 1 BOX (72484-433-03) > 1.2 mL in 1 PACKET3 packet2019-01-100000-00-00NoNoCurrent
72484-433-05724840433055 PACKET in 1 BOX (72484-433-05) / 1.2 mL in 1 PACKET5 packet2020-12-170000-00-00NoNoCurrent
72484-433-08724840433088 PACKET in 1 BOX (72484-433-08) / 1.2 mL in 1 PACKET8 packet2019-01-100000-00-00NoNoCurrent
72484-433-127248404331212 PACKET in 1 BOX (72484-433-12) / 1.2 mL in 1 PACKET12 packet2022-06-280000-00-00NoNoCurrent