NDC 49781-091

Leader

Phenylephrine Hydrochloride And Witch Hazel

Leader is a Rectal Cream in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Phenylephrine Hydrochloride; Witch Hazel.

• Product ID: 49781-091_cb63faac-995c-4868-9980-e433005b2a85
• NDC: 49781-091
• Product Type: Human Otc Drug
• Proprietary Name: Leader
• Generic Name: Phenylephrine Hydrochloride And Witch Hazel
• Dosage Form: Cream
• Route of Administration: RECTAL
• Marketing Start Date: 2014-04-28
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part346
• Labeler Name: Cardinal Health
• Substance Name: PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
• Active Ingredient Strength: 3 mg/L; mg/L
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 49781-091-01

1 TUBE in 1 CARTON (49781-091-01) > .026 L in 1 TUBE

• Marketing Start Date: 2014-04-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49781-091-01 [49781009101]

Leader CREAM

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-04-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/L

OpenFDA Data

• SPL SET ID: 126d0cf5-4619-45c5-88dc-7028a11787fb
• Manufacturer:
  • Cardinal Health
• UNII:
  • 101I4J0U34
  • 04JA59TNSJ

NDC Crossover Matching brand name "Leader" or generic name "Phenylephrine Hydrochloride And Witch Hazel"

NDC	Brand Name	Generic Name
37205-665	Leader	Psyllium Husk
37205-666	Leader	Psyllium Husk
37205-667	Leader	Psyllium Husk
37205-721	Leader	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
37205-722	Leader	Octinoxate, Oxybenzone
37205-724	Leader	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
37205-725	Leader	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
37205-726	Leader	Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone
37205-727	Leader	Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone
37205-728	Leader	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
37205-729	Leader	Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
37205-730	Leader	Homosalate, Octisalate, Oxybenzone, Avobenzone
37205-731	Leader	Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone
37205-732	Leader	Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone
49781-090	Leader	Glycerin, Petrolatum, Phenylephrine Hydrochloride and Pramoxine Hydrochloride
49781-091	Leader	phenylephrine hydrochloride and witch hazel
70000-0016	Leader	avobenzone, homosalate, octisalate, octocrylene, oxybenzone
69842-843	CVS HEALTH HEMORRHOIDAL COOLING	PHENYLEPHRINE HYDROCHLORIDE and WITCH HAZEL
37205-615	Ear Wax Removing Drops	Leader
55910-416	REXALL HEMORRHOIDAL COOLING	Phenylephrine Hydrochloride and Witch Hazel