NDC 55758-316

FlexSport Roll On

Menthol

FlexSport Roll On is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Pharmadel Llc. The primary component is Menthol.

• Product ID: 55758-316_86d21b0d-c256-6b4f-e053-2a91aa0a0283
• NDC: 55758-316
• Product Type: Human Otc Drug
• Proprietary Name: FlexSport Roll On
• Generic Name: Menthol
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-04-04
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Pharmadel LLC
• Substance Name: MENTHOL
• Active Ingredient Strength: 16 g/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55758-316-02

1 BOTTLE, WITH APPLICATOR in 1 BOX (55758-316-02) > 1 CREAM in 1 BOTTLE, WITH APPLICATOR

• Marketing Start Date: 2019-04-04
• Marketing End Date: 2021-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55758-316-02 [55758031602]

FlexSport Roll On CREAM

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-04-04

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	16 g/1

OpenFDA Data

• SPL SET ID: 85b8ef3d-72fa-7f3b-e053-2991aa0a0777
• Manufacturer:
  • Pharmadel LLC
• UNII:
  • L7T10EIP3A

NDC Crossover Matching brand name "FlexSport Roll On" or generic name "Menthol"

NDC	Brand Name	Generic Name
55758-316	FlexSport Roll On	FlexSport Roll On
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