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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Family wellness
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT5L8T28FGP, 4T6H12BN9U, 04JA59TNSJ
Rxcui1372298

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

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