NDC 0135-0620

PANADOL Extra

Acetaminophen And Caffeine

PANADOL Extra is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Acetaminophen; Caffeine.

• Product ID: 0135-0620_3337f0bf-e1ea-4303-84b5-005e2d47fd79
• NDC: 0135-0620
• Product Type: Human Otc Drug
• Proprietary Name: PANADOL Extra
• Generic Name: Acetaminophen And Caffeine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• Substance Name: ACETAMINOPHEN; CAFFEINE
• Active Ingredient Strength: 500 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0135-0620-01

1 BOTTLE in 1 CARTON (0135-0620-01) > 24 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2017-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0135-0620-01 [00135062001]

PANADOL Extra TABLET, FILM COATED

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-03-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	500 mg/1

OpenFDA Data

• SPL SET ID: e5c2d88a-d903-4ca0-b895-f27e791dfc4e
• Manufacturer:
  • GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• UNII:
  • 362O9ITL9D
  • 3G6A5W338E
• RxNorm Concept Unique ID - RxCUI:
  • 307686
  • 1872075

NDC Crossover Matching brand name "PANADOL Extra" or generic name "Acetaminophen And Caffeine"

NDC	Brand Name	Generic Name
63029-629	Goodys Headache Relief Shot	Acetaminophen and Caffeine
63029-639	Goodys Headache Relief Shot	Acetaminophen and Caffeine
51596-010	Headache Relief To Go	acetaminophen and caffeine
51596-011	Headache Relief To Go	acetaminophen and caffeine
0135-0620	PANADOL	acetaminophen and caffeine
0363-7213	TENSION HEADACHE RELIEF	ACETAMINOPHEN AND CAFFEINE
68210-0019	TENSION HEADACHE RELIEF	ACETAMINOPHEN AND CAFFEINE
68210-0190	TENSION HEADACHE RELIEF	ACETAMINOPHEN AND CAFFEINE
68210-4108	TENSION HEADACHE RELIEF	ACETAMINOPHEN AND CAFFEINE
68210-4146	TENSION HEADACHE RELIEF	ACETAMINOPHEN AND CAFFEINE
68210-4184	Tension Headache Relief	Acetaminophen and Caffeine
68210-4239	TENSION HEADACHE RELIEF	ACETAMINOPHEN AND CAFFEINE
68210-4241	TENSION HEADACHE RELIEF	ACETAMINOPHEN AND CAFFEINE