FDA.reportPublic FDA data

Dr. Numb

Product NDC
69903-002
11-digit product format
699030002
Labeler code
69903
Product ID
69903-002_50b50aba-23c0-623d-e063-6394a90ab2eb
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine and Benzethonium Chloride Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Shinpharma Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-12
Substance
LIDOCAINE; BENZETHONIUM CHLORIDE
Active strength
4; .25 mg/50g; mg/50g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct69903-002IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69903-00269903-002-50IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
Dr. Numb
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 mg/50g
BENZETHONIUM CHLORIDE.25 mg/50g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
PH41D05744Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8cdccdb-775b-4970-a6ea-50b62df221d6Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-04-03Drug Facts
2024-01-30Drug Facts
2021-02-12Drug Facts
2021-01-29Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69903-002-50Dr. Numb1 in 1 CARTRIDGECREAM16
69903-002-50Dr. Numb50 g in 1 TUBECREAM506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69903-002DR. NUMB (LIDOCAINE AND BENZETHONIUM CHLORIDE CREAM) CREAM [SHINPHARMA INC]5Current NDC, Legacy NDC, 2 package rows20240405_d8cdccdb-775b-4970-a6ea-50b62df221d6.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 115 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATENatural Essentials, Inc.f7198485-3d68-41d2-b9b9-f932a06493102024-12-04WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
application number: M017
Bite and ItchDIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEWeeks & Leo Co., Inc.0a4d471b-c3f3-0a6a-e063-6394a90ad57b2024-12-03WarningsExact identifier
application number: M017
MentholAMISH ORIGINS MEDICATEDAmish Origins LLC547abe39-3af3-4d70-99dd-caf8d67feda22024-12-03WarningsExact identifier
application number: M017
Meijer Small Cold-Hot Medicated PatchesMENTHOLMeijer Distribution Incbe6012d6-2062-45ba-8fc4-abf14cff58452024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.acdd5622-a9a7-4cc3-877e-57efea23303f2024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff52024-12-03WarningsExact identifier
application number: M017
Salonpas DEEP RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu America, Inc.a4ddb2b9-d023-4c8c-9285-93d51f93207d2024-12-03WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief - OvernightLIDOCAINETelebrands Corp1030d478-6805-6579-e063-6294a90a0c762024-12-02WarningsExact identifier
application number: M017
Campho-Phenique Cold Sore TreatmentCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC106c0bb2-f2e2-4255-867d-d09ff6a5a2e62024-12-02WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC82edaef0-0709-4ae1-a664-c9c5adb91ee12024-12-02WarningsExact identifier
application number: M017
Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll OnTHERMACARE CAPSAICIN ROLL ONClarion Brands LLC2850f7e7-41dd-f5f9-e063-6394a90ae5192024-12-02WarningsExact identifier
application number: M017
BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENINGBO TIANBO FIRST AID PRODUCT CO., LTD.2ec1cf79-c341-4b79-9047-ce29f0dff4192024-11-29WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare242204d3-efc7-f7a9-e063-6294a90a5af12024-11-27WarningsExact identifier
application number: M017
Walgreens Flexible Pain Relieving LidocaineLIDOCAINE, MENTHOLWalgreen Co.6f070fa3-a61a-4523-a470-ab58bf9400a32024-11-27WarningsExact identifier
application number: M017
Benadryl Original Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC920c50cb-9bdd-4a36-bb3d-c2559db733272024-11-26WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC884907a8-c884-4cce-ac10-9d4848fdba3e2024-11-22WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC7f067e95-e01c-4b9a-a02e-0af097beb18c2024-11-22WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC9ece9b3a-0092-4c1c-a913-c2fefcd705412024-11-22WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69903-002-50699030002501 TUBE in 1 CARTRIDGE (69903-002-50) / 50 g in 1 TUBE1 tube2017-09-120000-00-00NoNoCurrent