Over-the-counter drug · OTC MONOGRAPH DRUG

Excedrin Extra Strength Headache (Acetaminophen, aspirin (nsaid), caffeine) NDC 0067-2003

Acetaminophen 250 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Haleon US Holdings LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)0067-2003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00067-2003Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0067-2003-01000672003011 BOTTLE in 1 CARTON (0067-2003-01) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 1, 2024
0067-2003-02000672003021 BOTTLE in 1 CARTON (0067-2003-02) / 200 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 1, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Excedrin Extra Strength HeadacheSuffix: Extra Strength Headache
Generic name (nonproprietary)
acetaminophen, aspirin (nsaid), caffeine
Active ingredients
Acetaminophen — 250 mg/1Aspirin — 250 mg/1Caffeine — 65 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Haleon US Holdings LLCNDC labeler code 0067
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Cyclooxygenase Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)Decreased Prostaglandin Production (Physiologic effect)Xanthines (Chemical structure)
Identifiers
Product ID 0067-2003_1005a911-f3ad-23c9-e063-6294a90abb9fSPL ID 1005a911-f3ad-23c9-e063-6294a90abb9fSPL set ID 61802b27-c9ec-4386-9d44-45e8b1e558b7RxCUI 209468, 308297UNII 3G6A5W338E, 362O9ITL9D, R16CO5Y76E
Pharmacologic class
Central Nervous System Stimulant; Methylxanthine; Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400067200301 followed by a unit qualifier and the quantity

Package 00067-2003-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0067-2003

What is NDC 0067-2003?
0067-2003 is the product NDC for Excedrin Extra Strength Headache, Acetaminophen 250 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Excedrin Extra Strength Headache (Acetaminophen, Aspirin (NSAID), Caffeine).
What is the active ingredient?
Acetaminophen, Aspirin, Caffeine.
Who is the labeler?
Haleon US Holdings LLC, NDC labeler code 0067. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Excedrin Extra Strength Headache?
3 other product NDCs are listed under this name. See all Excedrin Extra Strength Headache NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Excedrin Extra Strength Headache NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Excedrin Extra Strength Headacheacetaminophen, aspirin (nsaid), caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralR J General Corporation70264-04570264-0045-01
Excedrin Extra Strength Headacheacetaminophen, aspirin (nsaid), caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralHaleon US Holdings LLC0067-200200067-2002-0100067-2002-0200067-2002-03+5 more
Excedrin Extra Strength Headacheacetaminophen, aspirin (nsaid), caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralSelect Consumer Group85237-186885237-1868-0185237-1868-0285237-1868-03+1 more

Other NDCs under M 013

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 013
ProductStrengthForm · routeLabelerProduct NDC
Xesso NeobenzocaineBenzocaine 5 g/100mLSprayOral, TopicalPREMIUM NATURAL COSMETICS INC81777-106
MAX relief junior Grapechildrens acetaminophenAcetaminophen 160 mg/5mLLiquidOralATLANTIC BIOLOGICALS CORP.17856-1123
equate aspirinaspirinAspirin 81 mg/1Tablet, ChewableOralWal-Mart Stores Inc49035-467
AcetaminophenAcetaminophen 325 mg/1TabletOralCardinal Health 107, LLC55154-7899
AcetaminophenAcetaminophen 325 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-346
Bayer Rapid Reliefaspirin/caffeine oral powderCaffeine 65 mg/1; Aspirin 650 mg/1PowderOralBayer HealthCare LLC.0280-0103
AcetaminophenAcetaminophen 650 mg/20.3mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-3141
Headache Reliefacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralDOLGENCORP, LLC55910-345
Aspirin Enteric Coated, Regular StrengthaspirinAspirin 325 mg/1Tablet, Delayed releaseOralWalgreen Company0363-0227
AspirinAspirin 325 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-205
MAX relief junior Grapechildrens acetaminophenAcetaminophen 160 mg/5mLLiquidOralATLANTIC BIOLOGICALS CORP.17856-1122
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralH E B37808-195
childrens mapapacetaminophenAcetaminophen 160 mg/1Tablet, ChewableOralProficient Rx LP71205-322
AcetaminophenAcetaminophen 500 mg/1TabletOralWALMART INC79903-296
Extra Strength Pain Relieveracetaminophen 500 mgAcetaminophen 500 mg/1TabletOralLil' Drug Store Products, Inc.29485-9281
AcetaminophenAcetaminophen 500 mg/1TabletOralCardinal Health 107, LLC55154-7897
Headache Formula Extra Strengthacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralARMY AND AIR FORCE EXCHANGE SERVICE55301-334
AcetaminophenAcetaminophen 500 mg/1TabletOralFamily Dollar, Inc.55319-751
Alka-Seltzerbuffered aspirinAspirin 325 mg/1Tablet, EffervescentOralLil' Drug Store Products, Inc.66715-5206
Extra Strength Pain ReliefacetaminophenAcetaminophen 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8786

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Excedrin Extra Strength Headache NDC 0067-2003 | Med-Code