first aid direct headache and congestion sinus relief

Generic: acetaminophen phenylephrine hcl

Labeler: cintas corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name first aid direct headache and congestion sinus relief
Generic Name acetaminophen phenylephrine hcl
Labeler cintas corporation
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Cintas Corporation

Identifiers & Regulatory

Product NDC 42961-126
Product ID 42961-126_a56952af-71d6-4bf4-995d-4e52b1f346c4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-09-26

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42961126
Hyphenated Format 42961-126

Supplemental Identifiers

RxCUI
1101534
UNII
362O9ITL9D 04JA59TNSJ

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 first aid direct headache and congestion sinus relief (source: ndc)
Generic Name acetaminophen phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 25 PACKET in 1 BOX (42961-126-02) / 2 TABLET in 1 PACKET (42961-126-01)
source: ndc

Packages (1)

42961-126-02 25 PACKET in 1 BOX (42961-126-02) / 2 TABLET in 1 PACKET (42961-126-01)

Ingredients (2)

acetaminophen (500 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

First Aid Direct Headache and Congestion Sinus Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a56952af-71d6-4bf4-995d-4e52b1f346c4", "openfda": {"unii": ["362O9ITL9D", "04JA59TNSJ"], "rxcui": ["1101534"], "spl_set_id": ["a518e124-5a96-4a08-9b5f-3eaa8bf944c0"], "manufacturer_name": ["Cintas Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 PACKET in 1 BOX (42961-126-02)  / 2 TABLET in 1 PACKET (42961-126-01)", "package_ndc": "42961-126-02", "marketing_start_date": "20230926"}], "brand_name": "First Aid Direct Headache and Congestion Sinus Relief", "product_id": "42961-126_a56952af-71d6-4bf4-995d-4e52b1f346c4", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "42961-126", "generic_name": "Acetaminophen Phenylephrine HCl", "labeler_name": "Cintas Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "First Aid Direct Headache and Congestion Sinus Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230926", "listing_expiration_date": "20261231"}