NDC 41250-417OTC monographFDA ANDA · ANDA076518

Sinus and Cold D

Active substance: Naproxen sodium, Pseudoephedrine HCl

FDA labeler: Meijer Distribution Inc

5 formulations • 5 package configurations
All 10 registered NDCs — click to copy
In one line

Sinus and Cold D (Naproxen sodium, Pseudoephedrine HCl) NDC 41250-417 converts to 41250-0417-01 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk
Listing: 41250-417
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel
NDC direct
Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).
Standard pharmacy claim — no J-Code required
11-digit HIPAA NDC
41250-0417-01
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
Self-Administered (Oral)
Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.
UB-04 revenue code
Rev 0250
0250 (General Pharmacy)
Qualifier: UN
Complete drug registry

All registered strengths & packaging

Every registered strength and package for Sinus and Cold D, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
220 mg/1, 120 mg/141250-417-0141250-41741250-0417-0120 BLISTER PACK in 1 CARTON (41250-417-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
220 mg/1, 120 mg/170000-0605-170000-060570000-0605-0120 BLISTER PACK in 1 CARTON (70000-0605-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
220 mg/1, 120 mg/10363-0650-010363-065000363-0650-0120 BLISTER PACK in 1 CARTON (0363-0650-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
220 mg/1, 120 mg/136800-417-0136800-41736800-0417-0120 BLISTER PACK in 1 CARTON (36800-417-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
220 mg/1, 120 mg/151316-339-0151316-33951316-0339-0120 BLISTER PACK in 1 CARTON (51316-339-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
FDA drug label

Prescribing information

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections
Uses temporarily relieves these cold, sinus, and flu symptoms: • sinus pressure • minor body aches and pains • headache • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) • fever
Directions • do not take more than directed • the smallest effective dose should be used • swallow whole; do not crush or chew • drink a full glass of water with each dose • adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours • children under 12 years: do not use
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • in children under 12 years of age Ask a doctor before use if • the stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke • you are taking a diuretic • you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin • taking any other drug When using this product • take with food or milk if stomach upset occurs Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • redness or swelling is present in the painful area • any new symptoms appear • fever gets worse or lasts more than 3 days • you have difficulty swallowing or the caplet feels stuck in your throat • you get nervous, dizzy, or sleepless • nasal congestion lasts more than 7 days If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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