dual action pain relief

Generic: acetaminophen, ibuprofen

Labeler: time cap laboratories, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dual action pain relief
Generic Name acetaminophen, ibuprofen
Labeler time cap laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-716
Product ID 49483-716_08acd3bf-ad0d-f693-e063-6394a90ad8c2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216994
Listing Expiration 2026-12-31
Marketing Start 2023-10-13

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49483716
Hyphenated Format 49483-716

Supplemental Identifiers

RxCUI
2387532
UPC
0349483716757 0349483716498
UNII
362O9ITL9D WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dual action pain relief (source: ndc)
Generic Name acetaminophen, ibuprofen (source: ndc)
Application Number ANDA216994 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (49483-716-49) / 144 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (49483-716-75) / 72 TABLET in 1 BOTTLE
source: ndc

Packages (2)

49483-716-49 1 BOTTLE in 1 CARTON (49483-716-49) / 144 TABLET in 1 BOTTLE 49483-716-75 1 BOTTLE in 1 CARTON (49483-716-75) / 72 TABLET in 1 BOTTLE

Ingredients (2)

acetaminophen (250 mg/1) ibuprofen (125 mg/1)

Linked Drug Pages (1)

Dual Action Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "08acd3bf-ad0d-f693-e063-6394a90ad8c2", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0349483716757", "0349483716498"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["08acd3bf-ad0c-f693-e063-6394a90ad8c2"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (49483-716-49)  / 144 TABLET in 1 BOTTLE", "package_ndc": "49483-716-49", "marketing_start_date": "20231013"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (49483-716-75)  / 72 TABLET in 1 BOTTLE", "package_ndc": "49483-716-75", "marketing_start_date": "20231013"}], "brand_name": "Dual Action Pain Relief", "product_id": "49483-716_08acd3bf-ad0d-f693-e063-6394a90ad8c2", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "49483-716", "generic_name": "Acetaminophen, Ibuprofen", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dual Action Pain Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA216994", "marketing_category": "ANDA", "marketing_start_date": "20231013", "listing_expiration_date": "20261231"}