FDA.reportPublic FDA data

Dermoplast Post Partum

Product NDC
16864-640
11-digit product format
168640640
Labeler code
16864
Product ID
16864-640_374dced3-6528-b458-e063-6394a90a911e
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Advantice Health, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
BENZOCAINE
Active strength
200 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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
Dermoplast Post Partum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
211316Internal RxNorm lookup
360349Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
374dced3-6527-b458-e063-6394a90a911eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-640-01Dermoplast Post Partum78 g in 1 CANAEROSOL, SPRAY781

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16864-640-01GM - Gram16864-640bef2525f-b70a-4984-ae22-61caf0d5a22a12025-11-13

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 17 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DCH Rapid Relief HemorrhoidalLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labs00eef84c-a72e-3343-e063-6294a90aa4d82024-12-19WarningsExact identifier
application number: M015
Formula 2 Skin CareLIDOCAINE 5%Derma Care Research Labsa05d5e07-ae4b-38cc-e053-2a95a90abced2024-12-19WarningsExact identifier
application number: M015
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
application number: M015
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELTrifecta Pharmaceuticals Usa Llc651c0143-384c-3649-e053-2991aa0a0f282024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
application number: M015
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal PadsWITCH HAZELDickinson Brands Inc.1b50f4dc-c26a-431a-ae18-c43513871b392024-12-18WarningsExact identifier
application number: M015
RECTICARELIDOCAINEFerndale Laboratories, Inc.49cb48cf-7a26-4d7a-887f-2e98261d269d2024-12-17WarningsExact identifier
application number: M015
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
application number: M015
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
application number: M015
PRAXPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.674f0d8b-3d50-42b1-8401-d2967bcdf5cf2024-12-17WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
application number: M015
Warrior Rectal CareLIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labsfc10cbc3-fc1b-ae09-e053-6394a90ac8f32024-12-15WarningsExact identifier
application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)GLYCERIN, LIDOCAINE, AND WITCH HAZELBlistex Inca7cb6d78-3048-43b3-afe7-4d862fdcfd3f2024-12-13WarningsExact identifier
application number: M015
Tucks Medicated Cooling PadsWITCH HAZELBlistex Incb3e68008-3d0d-4124-9579-b503e9fb95c92024-12-13WarningsExact identifier
application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.2a4273a4-3bda-4653-a065-cd4578053f3c2024-12-12WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELMedical Products Laboratories, Inc.b815792f-2f8f-7ac8-e053-2995a90ade182024-12-11WarningsExact identifier
application number: M015
ZensaLIDOCAINEAlera Skin Care Products Inc.f56146b6-3c11-4608-a6ab-6142f27e9ac32024-11-24WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360349benzocaine 20 % Topical SprayPSN374dced3-6527-b458-e063-6394a90a911e1
211316Dermoplast 20 % Topical SprayPSN374dced3-6527-b458-e063-6394a90a911e1
211316benzocaine 200 MG/ML Topical Spray [Dermoplast]SBD374dced3-6527-b458-e063-6394a90a911e1
360349benzocaine 200 MG/ML Topical SpraySCD374dced3-6527-b458-e063-6394a90a911e1
360349benzocaine 20 % Topical SpraySY374dced3-6527-b458-e063-6394a90a911e1
211316Dermoplast 20 % Topical SpraySY374dced3-6527-b458-e063-6394a90a911e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16864-640-011686406400178 g in 1 CAN (16864-640-01) 78 g2025-01-01NoNoCurrent