Signature Care Medicated Cooling

Product NDC
21130-928
11-digit product format
211300928
Labeler code
21130
Product ID
21130-928_41c453e3-2df4-0425-e063-6294a90ae663
Type
HUMAN OTC DRUG
Nonproprietary name
Witch Hazel
Dosage form
CLOTH
Route
TOPICAL
Labeler
Better Living Brands, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-03
Substance
WITCH HAZEL
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Signature Care Medicated Cooling
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
101I4J0U34Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
844379Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b35dc719-a5a2-4839-870d-25313d3f7c9bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-928-00Signature Care Medicated Cooling100 in 1 JARCLOTH1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-928SIGNATURE CARE MEDICATED COOLING (WITCH HAZEL) CLOTH [BETTER LIVING BRANDS, LLC]7Current NDC, Legacy NDC, 1 package rows20241228_b35dc719-a5a2-4839-870d-25313d3f7c9b.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 22 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family wellnessMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLFRONT PHARMACEUTICAL PLCcfdd61e3-e12e-491c-b2a8-90fae19e88702023-10-27WarningsExact identifier
application number: M015
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
application number: M015
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
application number: M015
Family WellnessPHENYLEPHRINE HCL, PETROLATUM, MINERALZhejiang Jingwei Pharmaceutical Co., Ltd.bfa195d7-d87f-43b5-bbf1-7ec3a451de052023-10-25WarningsExact identifier
application number: M015
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger CotsLIDOCAINECVS PHARMACY, INC82aa128a-44cd-4907-b0f7-8a31e086d3e62023-10-25WarningsExact identifier
application number: M015
TheraPlus PlusPHENYLEPHRINE HCIZhejiang Jingwei Pharmaceutical Co., Ltd.edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d2023-10-25WarningsExact identifier
application number: M015
Assured Bikini Smooth CreamLIDOCAINEZhejiang Jingwei Pharmaceutical Co., Ltd.fb9ddde3-3f40-467e-8aff-26570144f0fc2023-10-25WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
application number: M015
Family WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
application number: M015
Lidocaine 5%LIDOCAINEApnar Pharma LPceedce20-5723-5a9a-e053-2a95a90a17a12023-10-21WarningsExact identifier
application number: M015
Numquick Topical AnalgesicEPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDEUnit Dose, Ltd.3f64cbd3-6745-4397-9767-3adc3b301e0e2023-10-19WarningsExact identifier
application number: M015
Healquick Tattoo BalmPETROLATUMUnit Dose, Ltd.96f92c82-a79a-4d7e-ba0c-5ea67e2b6e862023-10-19WarningsExact identifier
application number: M015
Numpot Topical AnestheticLIDOCAINE, PETROLATUMUnit Dose, Ltd.9143b50b-7d76-4545-aa2e-1bb77ffb44ae2023-10-19WarningsExact identifier
application number: M015
Microcaine Topical AnalgesicLIDOCAINEUnit Dose, Ltd.5e8fa8b5-0524-4201-91e1-83e59a8f04152023-10-19WarningsExact identifier
application number: M015
NumstickPETROLATUM, LIDOCAINEUnit Dose, Ltd.127bbd87-5402-4da2-abf3-dac6367735ec2023-10-18WarningsExact identifier
application number: M015
ADVANCED NUMB Topical AnestheticLIDOCAINE HYDROCHLORIDEUber Scientific, LLC859d1cad-badf-4c42-9b08-daacb3fae8b42023-10-13WarningsExact identifier
application number: M015
Hemorrhoidal Pain Relief with Aloe and VitaminEHEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINENeilMed pharmaceuticals Inc.076b5021-8ba0-0204-e063-6294a90a33372023-10-11WarningsExact identifier
application number: M015
Zensa Numbing GelLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Alera Skin Care Products Inc.065a6eec-3896-0da8-e063-6394a90a849d2023-09-27WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
844379witch hazel 50 % Medicated PadPSNb35dc719-a5a2-4839-870d-25313d3f7c9b8
844379witch hazel 500 MG/ML Medicated PadSCDb35dc719-a5a2-4839-870d-25313d3f7c9b8
844379witch hazel 50 % Medicated PadSYb35dc719-a5a2-4839-870d-25313d3f7c9b8
844379witch hazel 50 % Medicated WipesSYb35dc719-a5a2-4839-870d-25313d3f7c9b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-928-0021130092800100 CLOTH in 1 JAR (21130-928-00) 100 cloth2016-10-030000-00-00NoNoCurrent