FDA.reportPublic FDA data

Tina Davies IceCream

Product NDC
84313-001
11-digit product format
843130001
Labeler code
84313
Product ID
84313-001_5282563a-c4f4-48d2-90ca-aac5fa7318ec
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride, Phenylephrine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
TINA DAVIES PROFESSIONAL LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-12
Marketing end
2028-04-30
Substance
LIDOCAINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; .25 g/100mL; g/100mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
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
Tina Davies IceCream

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE5 g/100mL
PHENYLEPHRINE HYDROCHLORIDE.25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2684985Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a2b3199-f405-4455-9a02-8885d24eef9cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
84313-001-05tina davies IceCream
84313-001-05tina davies IceCream
84313-001-05tina davies IceCream
84313-001-30tina davies IceCream
84313-001-30tina davies IceCream
84313-001-30tina davies IceCream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84313-001-05Tina Davies IceCream5 mL in 1 TUBECREAM52
84313-001-15Tina Davies IceCream1 in 1 CARTONCREAM12
84313-001-15Tina Davies IceCream15 mL in 1 TUBECREAM152
84313-001-30Tina Davies IceCream30 mL in 1 TUBECREAM302
84313-001-30Tina Davies IceCream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84313-001TINA DAVIES ICECREAM (LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) CREAM [TINA DAVIES PROFESSIONAL LLC]1Current NDC, 5 package rows20240614_6a2b3199-f405-4455-9a02-8885d24eef9c.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 1 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsExact identifier
application number: M015
BCBCYC Numbing CreamLIDOCAINE 5% NUMBING CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab36566-ba2f-06ef-e063-6394a90a71b52026-09-10WarningsExact identifier
application number: M015
5% Lidocaine 10g5% LIDOCAINEChongqing Mandongzi Technology Co., Ltd5b10530f-47cd-c4bd-e063-6294a90aaa0a2026-09-09WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum StrengthWITCH HAZELAmazon.com Services LLC41d756f3-e523-ed14-e063-6394a90ab8172026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch HazelHEMORRHOIDAL WIPES WITH WITCH HAZELBetter Living Brands LLCadf26111-70ba-596c-e053-2995a90ac6f12026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
up and up medicated wipes manixim strengthGENTLE HEMORRHOIDAL CARETarget Corporation271eab2b-ed13-39f1-e054-00144ff88e882026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOEWITCH HAZEL CLOTHThe Kroger Co.48c1598d-6667-446f-ac90-10ab945d06172026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazelWITCH HAZELOld East Main Co.2055289d-962e-46a9-b371-b5bb93dd46b42026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Equate Hemorrhoidal Medicated WipesWITCH HAZELWalmart Inc.8d57f054-77dc-4205-85f1-b65dcfde677b2026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Lidocaine CreamLIDOCAINEInvaDerm Corporation5a7273d1-1dbc-420e-e063-6294a90a86292026-09-01WarningsExact identifier
application number: M015
Lidocaine PhenylephrineLIDOCAINE PHENYLEPHRINEYYBA CORP5a72a190-2129-411e-e063-6394a90a08c22026-09-01WarningsExact identifier
application number: M015
INICEI 5% LIDOCAINE Numbing Cream5% LIDOCAINE NUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5a65842f-27a1-268b-e063-6294a90a60542026-08-31WarningsExact identifier
application number: M015
AnievaLCLIDOCAINEBlackstone Products, LLCddaba14c-10de-44e2-ae13-9217e20cb48e2026-08-29WarningsExact identifier
application number: M015
Norms Hemorrhoid WipesWITCH HAZELTotally Normal Company5a1af50b-8d00-f589-e063-6394a90af86c2026-08-28WarningsExact identifier
application number: M015
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.59f0fa16-5eb0-e6bb-e063-6294a90aacf52026-08-26WarningsExact identifier
application number: M015
Dude Hemorrhoidal WipesWITCH HAZELDude Productsfdf408ef-9392-a812-e053-6394a90a00172026-08-25WarningsExact identifier
application number: M015
Norms Medicated WipesWITCH HAZELTotally Normal Company3a78e109-3f7c-fb19-e063-6394a90ae78e2026-08-22WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2684985lidocaine hydrochloride 5 % / phenylephrine HCl 0.25 % Rectal CreamPSN6a2b3199-f405-4455-9a02-8885d24eef9c2
2684985lidocaine hydrochloride 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD6a2b3199-f405-4455-9a02-8885d24eef9c2
2684985lidocaine hydrochloride 5 % / phenylephrine hydrochloride 0.25 % Rectal CreamSY6a2b3199-f405-4455-9a02-8885d24eef9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
84313-001-05843130001055 mL in 1 TUBE (84313-001-05) 5 ml2024-06-122028-04-30YesNoHistorical
84313-001-15843130001151 TUBE in 1 CARTON (84313-001-15) / 15 mL in 1 TUBE1 tube2026-03-202028-04-30NoNoHistorical
84313-001-30843130001301 TUBE in 1 CARTON (84313-001-30) / 30 mL in 1 TUBE1 tube2024-06-122028-04-30NoNoHistorical