FDA.reportPublic FDA data

PREPARATION H MEDICATED WIPES

Product NDC
0573-0557
11-digit product format
005730557
Labeler code
0573
Product ID
0573-0557_12ae39cf-be29-3d34-e063-6394a90a3cc6
Type
HUMAN OTC DRUG
Nonproprietary name
witch hazel
Dosage form
CLOTH
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-01
Substance
WITCH HAZEL
Active strength
5 g/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PREPARATION H MEDICATED WIPES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL5 g/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
3b1cfa8a-942f-471e-b7c0-744f83b687a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0557-01PREPARATION H MEDICATED WIPES48 in 1 POUCHCLOTH483
0573-0557-02PREPARATION H MEDICATED WIPES2 in 1 CARTONCLOTH23
0573-0557-02PREPARATION H MEDICATED WIPES48 in 1 POUCHCLOTH483
0573-0557-03PREPARATION H MEDICATED WIPES60 in 1 POUCHCLOTH603
0573-0557-03PREPARATION H MEDICATED WIPES3 in 1 CARTONCLOTH33
0573-0557-04PREPARATION H MEDICATED WIPES4 in 1 CARTONCLOTH43
0573-0557-04PREPARATION H MEDICATED WIPES48 in 1 POUCHCLOTH483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0557PREPARATION H MEDICATED WIPES (WITCH HAZEL) CLOTH [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 7 package rows20240303_3b1cfa8a-942f-471e-b7c0-744f83b687a0.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 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gembooxt Topical Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-08-12WarningsExact identifier
application number: M015
NumbMD Lidocaine Cream Anorectal(hemorrhoidal)LIDOCAINE 5%EveryMarket Inc52379055-d017-4d98-e063-6294a90a196c2026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc52369a41-820d-cd7a-e063-6394a90ac6d12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc51d370b4-1c34-d203-e063-6394a90a80b12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD 5% Lidocaine creamLIDOCAINE 5%EveryMarket Inc507d0c2c-9517-40f8-e063-6394a90a19962026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)LIDOCAINE CREAM ANORECTALEveryMarket Inc483d81a3-7493-3391-e063-6394a90a2e3d2026-08-12WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINE100 KARMA INC35b5ba9d-da1d-55d6-e063-6294a90a5fa82026-08-12WarningsExact identifier
application number: M015
Treatonic hemorrhoid treatment5% LIDOCAINE100 KARMA INC41442fa7-c511-07ca-e063-6294a90a39922026-08-12WarningsExact identifier
application number: M015
Lidocaine numbing cream5% LIDOCAINE100 KARMA INC47380721-6633-4a50-e063-6394a90aca942026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC47dc7630-9a74-1989-e063-6294a90a50bb2026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC49e6b69f-bd6e-b415-e063-6394a90a8e652026-08-12WarningsExact identifier
application number: M015
THE SOLU TIONLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDESCALP TECH INC58793581-8826-9a74-e063-6294a90a24652026-08-06WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-08-03WarningsExact identifier
application number: M015
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEYYBA CORP582a0001-da1e-909a-e063-6394a90a2b112026-08-03WarningsExact identifier
application number: M015
up and upPHENYLEPHRINE HYDROCHLORIDETarget Corporationb42775ae-44fe-487e-b9ca-21d9687020a92026-07-29WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd578fa642-ff30-e511-e063-6294a90a59872026-07-26WarningsExact identifier
application number: M015
CVS Topical Anesthetic HemorrhoidalDIBUCAINECVS PHARMACY, INC9f3d4fdb-ad82-4ab8-8a9e-252d027068ab2026-07-25WarningsExact identifier
application number: M015
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
application number: M015
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
844379witch hazel 50 % Medicated PadPSN3b1cfa8a-942f-471e-b7c0-744f83b687a03
844379witch hazel 500 MG/ML Medicated PadSCD3b1cfa8a-942f-471e-b7c0-744f83b687a03
844379witch hazel 50 % Medicated PadSY3b1cfa8a-942f-471e-b7c0-744f83b687a03
844379witch hazel 50 % Medicated WipesSY3b1cfa8a-942f-471e-b7c0-744f83b687a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0557-010057305570148 CLOTH in 1 POUCH (0573-0557-01) 48 cloth2022-08-010000-00-00NoNoCurrent
0573-0557-02005730557022 POUCH in 1 CARTON (0573-0557-02) / 48 CLOTH in 1 POUCH2 pouch2022-08-010000-00-00NoNoCurrent
0573-0557-03005730557033 POUCH in 1 CARTON (0573-0557-03) / 60 CLOTH in 1 POUCH3 pouch2022-08-010000-00-00NoNoCurrent
0573-0557-04005730557044 POUCH in 1 CARTON (0573-0557-04) / 48 CLOTH in 1 POUCH4 pouch2022-08-010000-00-00NoNoCurrent