NDC 59105-004

ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and PHENYLEPHRINE HYDROCHLORIDE

Acetaminophen, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide

ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and PHENYLEPHRINE HYDROCHLORIDE is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by J.p. Business Enterprise. The primary component is Acetaminophen; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

• Product ID: 59105-004_9aa93d88-446d-b83b-e053-2a95a90ac6c8
• NDC: 59105-004
• Product Type: Human Otc Drug
• Proprietary Name: ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and PHENYLEPHRINE HYDROCHLORIDE
• Generic Name: Acetaminophen, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2014-12-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Labeler Name: J.P. BUSINESS ENTERPRISE
• Substance Name: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59105-004-10

1 BLISTER PACK in 1 CARTON (59105-004-10) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2014-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59105-004-10 [59105000410]

ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-12-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: a38fea87-a244-4de6-9715-5da78b8ac17b
• Manufacturer:
  • J.P. BUSINESS ENTERPRISE
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1086997

NDC Crossover Matching brand name "ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and PHENYLEPHRINE HYDROCHLORIDE" or generic name "Acetaminophen, Phenylephrine Hydrochloride, And Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
59105-004	ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and PHENYLEPHRINE HYDROCHLORIDE	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE
68210-1490	D - TIME	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE