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 firm2026-10-21
excluded packagepackage72484-43372484-433-03DDiscontinued by firm2026-10-21

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 143 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheffield Arthritis and Muscle Pain ReliefCAPSICUM OLEORESINSheffield Pharmaceuticals LLC724b9870-e86a-4087-ba78-8c944ce3baa62023-11-28WarningsExact identifier
application number: M017
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMSheffield Pharmaceuticals LLC60d1d826-a53e-42e5-bc30-1b2c2690445b2023-11-28WarningsExact identifier
application number: M017
Thera Plus Cold Therapy Pain Relieving MentholMENTHOLFourstar Group USA, Inc.0a462c91-5300-e282-e063-6394a90a4cc22023-11-27WarningsExact identifier
application number: M017
UtaSprayMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLCc641ab11-cd00-4e23-ace7-8178739084f02023-11-21WarningsExact identifier
application number: M017
Top Medicated OilCAMPHOR, MENTHOL, METHYL SALICYLATEBig 5 Nutrition LLCb2f0d1e1-7d03-434e-be39-9f980459690c2023-11-21WarningsExact identifier
application number: M017
BT Pain Relief BalmMETHYL SALICYLATE, MENTHOL, CAMPHORBig 5 Nutrition LLC50112419-c934-4d3a-9ea6-9b089f516a6d2023-11-21WarningsExact identifier
application number: M017
BT Pain ReliefMENTHOL, METHYL SALICYLATEBig 5 Nutrition LLC91324910-27cf-424f-9e9b-6173f2d7acbf2023-11-21WarningsExact identifier
application number: M017
Dit Da ShuiMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLC5d45cb48-3e88-4d58-81d2-6f88d7a821342023-11-20WarningsExact identifier
application number: M017
Herbal BalmMETHYL SALICYLATE, MENTHOL ANDBig 5 Nutrition LLC09b3b86d-3434-428b-b0a8-e8dfd7c0b52a2023-11-20WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesb505769e-9c46-3cf3-e053-2a95a90a4df92023-11-17WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesd6523993-d781-cdbc-e053-2a95a90af1912023-11-17WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.4d91baf3-9655-4786-93b8-aa0d93fe0bf92023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPMENTHOLKOBAYASHI Healthcare International, Inc.7ef03298-6623-4cf4-b21f-74b2ffc11c6e2023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.436e8578-b609-4b45-8f84-0d111140fda62023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOLKOBAYASHI Healthcare International, Inc.08dcfa78-7332-4f19-90d7-fdd7d446848a2023-11-16WarningsExact identifier
application number: M017
Totally Fun After SunLIDOCAINE HCLMJ Products Association, LLC965a2a29-914c-4ad0-b25f-5df3c30da3932023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f2023-11-15WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.b44beac3-1d20-434f-9a79-4fab1ac687912023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC79ad55eb-b59d-4bb8-88e3-3b51e10a7f282023-11-15WarningsExact identifier
application number: M017
PURE EASE Joint Muscle lnstant Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.42bf129c-5c84-4331-b6d0-78e3be71a9852023-11-13WarningsExact 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