NDC 71798-005

PS

Menthol

PS is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by New Leaf Pharmaceutical, Llc. The primary component is Menthol, Unspecified Form.

• Product ID: 71798-005_9cf71ce2-8b39-22eb-e053-2a95a90a0d98
• NDC: 71798-005
• Product Type: Human Otc Drug
• Proprietary Name: PS
• Generic Name: Menthol
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-04-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: New Leaf Pharmaceutical, LLC
• Substance Name: MENTHOL, UNSPECIFIED FORM
• Active Ingredient Strength: 16 g/16mg
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 71798-005-03

88.7 mg in 1 JAR (71798-005-03)

• Marketing Start Date: 2020-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71798-005-03 [71798000503]

PS OINTMENT

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-04-01

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	16 g/16mg

OpenFDA Data

• SPL SET ID: 9cf71ce2-8b38-22eb-e053-2a95a90a0d98
• Manufacturer:
  • New Leaf Pharmaceutical, LLC
• UNII:
  • L7T10EIP3A

NDC Crossover Matching brand name "PS" or generic name "Menthol"

NDC	Brand Name	Generic Name
71798-005	PS	PS
71798-006	PS	PS
0363-1071	Cherry Cough Drop	Menthol
0363-1086	Cherry Cough Drops	Menthol
0363-0150	Cool n Heat Patch for Arm, Neck and Leg	Menthol
0363-0152	Cool n Heat Patch for Back	Menthol
0363-1072	Honey Lemon Cough Drop	Menthol
0363-1087	Honey Lemon Cough Drop	Menthol
0219-0203	Humphreys Bendito Alcoholado	menthol
0363-1070	Menthol Cough Drop	menthol
0363-1084	Menthol Cough Drop	menthol
0067-2067	Mineral Ice	Menthol
0316-0226	Mineral Ice	Menthol
0316-0290	Mineral Ice Quick Dry Foam	Menthol
0363-0151	Pain Relieving Patch	Menthol
0363-1077	SF Honey Lemon Cough Drop	Menthol
0363-1085	SF Menthol Cough Drop	Menthol
0363-0043	Studio 35 Medicated Body	Menthol
0363-0864	Walgreens Cold Pain Relief	MENTHOL
0363-0874	Walgreens Cold Pain Relief	MENTHOL
0363-0966	Walgreens Sunburn Relief	Menthol