FDA.reportPublic FDA data

Family wellness

Product NDC
69571-006
11-digit product format
695710006
Labeler code
69571
Product ID
69571-006_08ad6b35-733b-c9d3-e063-6294a90acfed
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral oil, Petrolatum, Phenylephrine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
FRONT PHARMACEUTICAL PLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-30
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
14; 74.9; .25 g/100g; g/100g; g/100g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Family wellness
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL14 g/100g
PETROLATUM74.9 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T5L8T28FGPInternal UNII lookup
4T6H12BN9UInternal 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
1372298Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfdd61e3-e12e-491c-b2a8-90fae19e8870Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69571-006-01Family wellness57 g in 1 TUBEOINTMENT573
69571-006-02Family wellness1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69571-006FAMILY WELLNESS (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [FRONT PHARMACEUTICAL PLC]3Current NDC, Legacy NDC, 2 package rows20231027_cfdd61e3-e12e-491c-b2a8-90fae19e8870.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 5 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRMITSUI MEDICAL HAEMORRHOIDPHENYLEPHRINE HCI WITCH HAZELYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED51720221-893b-cade-e063-6394a90adaec2026-05-10WarningsExact identifier
application number: M015
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
application number: M015
Dr. NumbLIDOCAINEShinpharma Inc32ab24b4-dcec-4a09-e054-00144ff88e882026-04-30WarningsExact identifier
application number: M015
Dr. NumbLIDOCAINEShinpharma Incc2c0cb17-401a-4ba2-aa04-64c9b43cd21b2026-04-30WarningsExact identifier
application number: M015
Dr. NumbLIDOCAINEShinpharma Ince840fba4-86ff-9da0-e053-2995a90a221a2026-04-30WarningsExact identifier
application number: M015
FAMILY Wellness MEDICATED HEMORRHOIDAL WIPESWITCH HAZELFamily Dollar Stores, Inc3f6f68c0-787a-48eb-b042-d4df90ea7e032026-04-17WarningsExact identifier
application number: M015
Equaline HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa6ed1987-37ad-4bfd-8cea-f03426953f5a2026-04-16WarningsExact identifier
application number: M015
Verdibliss HEMORRHOID RELIEF OINTMENTSLIDOCAINE, PHENYLEPHRINEGuangdong Quadrant Ecological Technology Co., Ltd.4f1634d5-7667-b354-e063-6394a90a34e72026-04-10WarningsExact identifier
application number: M015
Hemorrhoidal Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
application number: M015
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
application number: M015
Walgreens Pain Relief with LidocaineLIDOCAINE, PHENYLEPHRINE HCLWalgreens Co3ce78f2f-0264-f406-e063-6294a90a7e032026-04-01WarningsExact identifier
application number: M015
LidocaineLIDOCAINEYYBA Corp5256a84a-8dac-8fd4-e063-6294a90a616c2026-04-01WarningsExact identifier
application number: M015
HemorrhoidalLIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUMWalgreens Co3d213ba8-3cbe-11c4-e063-6394a90ae0162026-03-30WarningsExact identifier
application number: M015
Critic Aid SkinZINC OXIDEColoplast Corpcaaac1f0-437d-4185-8670-9f11b9cefe632026-03-30WarningsExact identifier
application number: M015
CVS Topical Analgesic HemorrhoidalDIBUCAINECVS PHARMACY,INCb9e20531-3444-4955-b1d3-bb112340d2302026-03-27WarningsExact identifier
application number: M015
Walgreens Moisture BarrierWALGREENS MOISTURE BARRIERWalgreens44fc098c-1f5f-bf82-e063-6294a90a14052026-03-25WarningsExact identifier
application number: M015
LidocaineLIDOCAINEYYBA Corp472fe0d1-31a1-fded-e063-6394a90a4a662026-03-25WarningsExact identifier
application number: M015
Hemorrhoid Relief CreamLIDOCAINE 5% ANORECTALALAINA HEALTHCARE PRIVATE LIMITED53b2c3b0-d729-44d6-bc64-a9e1c93518772026-03-23WarningsExact identifier
application number: M015
LIDOCAINELIDOCAINEYYBA Corp4db609cc-f329-62a4-e063-6394a90aefc12026-03-23WarningsExact identifier
application number: M015
Topical Hemorrhoid Relief GelMENTHOL, UNSPECIFIED FORMYantai Aien Biotechnology Co., Ltd.4d6e6667-ab1c-de7c-e063-6294a90a0b9b2026-03-20WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSNcfdd61e3-e12e-491c-b2a8-90fae19e88703
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCDcfdd61e3-e12e-491c-b2a8-90fae19e88703
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSYcfdd61e3-e12e-491c-b2a8-90fae19e88703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69571-006-016957100060157 g in 1 TUBE57 gHistorical
69571-006-02695710006021 TUBE in 1 BOX (69571-006-02) / 57 g in 1 TUBE (69571-006-01) 1 tube2017-03-300000-00-00NoNoCurrent