FDA.reportPublic FDA data

Dr Talbots Cooling Perineal Pad

Product NDC
70797-104
11-digit product format
707970104
Labeler code
70797
Product ID
70797-104_30502321-9e0b-f1e0-e063-6394a90a4ed2
Type
HUMAN OTC DRUG
Nonproprietary name
Water, aloe barbadensis leaf juice, bioflavonoids, calendula officinalis flower extract, chamomilla recutita flower extract, citric acid, decyl glucoside, glycerin, lactic acid, levulinic acid, mentha piperita (peppermint) oil, sodium cocoamphoacetate, potassium sorbate
Dosage form
LIQUID
Route
TOPICAL
Labeler
Talbot's Pharmaceuticals family Products, LLC.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-08
Substance
WITCH HAZEL
Active strength
.5 g/g
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
Dr Talbots Cooling Perineal Pad
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL.5 g/g

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
242277e2-ff26-ad4e-e063-6394a90ab317Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70797-104-01Dr Talbots Cooling Perineal Pad120 g in 1 PACKAGELIQUID1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70797-104DR TALBOTS COOLING PERINEAL PAD (WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE) LIQUID [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC.]2Current NDC, 1 package rows20250316_242277e2-ff26-ad4e-e063-6394a90ab317.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 19 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMPerrigo Direct, Ince11470b2-80d6-4008-b87e-eb6aeadfce742026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEPerrigo Direct, Inccc0378f2-6d5f-47ec-b16a-64668b4c29cc2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMMeijer, Inc.adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEMeijer, Inc.1b72f927-c2ae-4190-a035-5d7bb9f53c152026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMMeijer, Inc.af293cc0-ccd5-42a6-861b-c19fa6ffd06a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMMeijer, Inc.09878fe0-0890-4af3-a3f6-d2890041e9f82026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEMeijer, Inc.fa8ae34c-7b68-454f-8a3b-0eaa93a340922026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Baby Diaper RashZINC OXIDEMeijer, Inc.04bec667-a11e-42d2-a4b3-1416eebf1e8d2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMMeijer, Inc.8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c12026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONEMeijer, Inc.75b91b97-ea84-4c4d-9e58-5a9ff27a778c2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALMeijer, Inc.d36a7479-7b3b-49fe-8144-b5cce0e173fb2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDAILY MOISTURIZINGMeijer, Inc.44949b46-70f2-4e52-adba-a8455da614eb2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELMeijer, Inc.13e4aece-5b91-4f89-a912-540bf170a8d12026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETarget Corporation7fb5f9ca-cd90-4933-9fe8-907ece00458b2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTarget Corporation5237c7f2-7135-4558-a758-4fc2a232172f2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMTarget Corporation3e620e4f-9e29-9e39-e063-6394a90adeda2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
844379witch hazel 50 % Medicated PadPSN242277e2-ff26-ad4e-e063-6394a90ab3172
844379witch hazel 500 MG/ML Medicated PadSCD242277e2-ff26-ad4e-e063-6394a90ab3172
844379witch hazel 50 % Medicated PadSY242277e2-ff26-ad4e-e063-6394a90ab3172
844379witch hazel 50 % Medicated WipesSY242277e2-ff26-ad4e-e063-6394a90ab3172

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70797-104-0170797010401120 g in 1 PACKAGE (70797-104-01) 120 g2024-08-08NoNoCurrent