FDA.reportPublic FDA data

Promescent

Product NDC
55636-590
11-digit product format
556360590
Labeler code
55636
Product ID
55636-590_5578bdd9-b03b-b909-e063-6294a90a0c79
Type
HUMAN OTC DRUG
Nonproprietary name
Lidicaine
Dosage form
SPRAY
Route
TOPICAL
Labeler
Absorption
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
LIDOCAINE
Active strength
10 g/100g
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 · 3 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
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct55636-590IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55636-59055636-590-74IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55636-59055636-590-13IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
Promescent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b508238-3be7-4b0d-bf35-51de79f58f55Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
55636-590-132020-03-10Promescent
55636-590-132020-03-10Promescent
55636-590-742020-03-10Promescent
55636-590-742020-03-10Promescent
55636-590-132019-11-27Promescent
55636-590-132019-11-27Promescent
55636-590-742019-11-27Promescent
55636-590-742019-11-27Promescent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55636-590-26Promescent1 in 1 CARTONSPRAY111
55636-590-26Promescent2.6 g in 1 BOTTLE, SPRAYSPRAY2.611
55636-590-52Promescent5.4 g in 1 BOTTLE, SPRAYSPRAY5.411
55636-590-52Promescent1 in 1 CARTONSPRAY111
55636-590-74Promescent7.4 g in 1 BOTTLE, SPRAYSPRAY7.411
55636-590-74Promescent1 in 1 CARTONSPRAY111

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LidocaineACTIVE INGREDIENT98PI200987PROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
LIDOCAINEACTIVE MOIETY98PI200987PROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
FARNESOLINACTIVE INGREDIENTEB41QIU6JLPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
HYDROGENATED POLYBUTENE (1300 MW)INACTIVE INGREDIENT7D1YQ9Y5EZPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62PROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
MACADAMIA OILINACTIVE INGREDIENT515610SU8CPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
STEAROXYTRIMETHYLSILANEINACTIVE INGREDIENT9862TW94B2PROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
THYMOLINACTIVE INGREDIENT3J50XA376EPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMESCENT (LIDICAINE) SPRAY [ABSORPTION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55636-590PROMESCENT (LIDICAINE) SPRAY [ABSORPTION]10Current NDC, Legacy NDC, 6 package rows20250504_5b508238-3be7-4b0d-bf35-51de79f58f55.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 59 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Ince2df8130-e7c8-4fde-a6d6-c713789912132025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incd04e473d-8bbc-475c-a0b1-ca5eed67fbc72025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Inccba7c084-379f-4a16-aeba-b11ca6e20d8a2025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Incd066002d-8ceb-4d16-9744-d5ca25d2ad5a2025-12-01WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc013beea4-b2c2-4e84-b4cb-3125ac48e8c02025-12-01WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINA2A Integrated Pharmaceuticals, LLC147f3594-7362-7a78-e063-6294a90a3e422025-11-30WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey6b9258e4-c7c4-765e-e053-2991aa0a9f4e2025-11-29WarningsExact identifier
application number: M017
Walgreen Pain Relieving Fragrance FreeLIDOCAINE HYDROCHLORIDEWALGREENS CO.62c50ded-3fc9-4f65-9bfb-1144ed2e36b42025-11-26WarningsExact identifier
application number: M017
Itch ReliefITCH RELIEF GELNeilmed Pharmaceuticals Inc.44811828-c32e-17fc-e063-6294a90add482025-11-26WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
application number: M017
Sohm Pain AwayMENTHOL, CAMPHORSOHM, Inc86632acf-80ae-48d7-a0bb-7ec980326bae2025-11-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Pain ReliefLIDOCAINE 4%Veridian Healthcare6f2332c0-e078-40a8-9564-f47d21bc491b2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC44779065-5f57-8f01-e063-6394a90a3f8e2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC44786cb6-176e-cc6e-e063-6394a90a54ad2025-11-25WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFVALU MERCHANDISERS, CO3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff2025-11-24WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDERVALU MERCHANDISERS, CO89a5c4bb-442f-d3f0-e053-2a95a90a51bd2025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d11ab8e-d3ea-c7ef-e063-6294a90ae0a32025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d113dec-8832-d984-e063-6394a90ae7b32025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d12f03f-dd8b-0be5-e063-6294a90a43db2025-11-24WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55636-590-13556360590131 BOTTLE, SPRAY in 1 CARTON (55636-590-13) > 1.3 g in 1 BOTTLE, SPRAY2013-01-110000-00-00NoNoCurrent
55636-590-26556360590261 BOTTLE, SPRAY in 1 CARTON (55636-590-26) / 2.6 g in 1 BOTTLE, SPRAY2024-01-010000-00-00NoNoCurrent
55636-590-52556360590521 BOTTLE, SPRAY in 1 CARTON (55636-590-52) / 5.4 g in 1 BOTTLE, SPRAY2024-01-010000-00-00NoNoCurrent
55636-590-74556360590741 BOTTLE, SPRAY in 1 CARTON (55636-590-74) / 7.4 g in 1 BOTTLE, SPRAY2024-01-010000-00-00NoNoCurrent