NDC codes

FDA NDC Directory
Product NDC (as listed)69168-462Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0462Add 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
69168-462-026916804620269168046202150 CAPSULE in 1 BOTTLE (69168-462-02)Marketed from Mar 29, 2024
69168-462-176916804621769168046217300 CAPSULE in 1 BOTTLE (69168-462-17)Marketed from Mar 7, 2025
69168-462-35691680462356916804623580 CAPSULE in 1 BOTTLE (69168-462-35)Marketed from Mar 29, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Dual Action Pain Relief
Generic name (nonproprietary)
dual action pain relief
Active ingredients
Acetaminophen — 250 mg/1Ibuprofen — 125 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Allegiant HealthNDC labeler code 69168
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216592
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 69168-462_cd52df09-a439-4a7e-b593-d2255f4a2275SPL ID cd52df09-a439-4a7e-b593-d2255f4a2275SPL set ID fb4fc347-0f90-429f-9ca8-903e736f5496UNII 362O9ITL9D, WK2XYI10QM

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

N469168046202 followed by a unit qualifier and the quantity

Package 69168-0462-02. 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)

Use(s) temporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o muscular aches o minor pain of arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69168-462

What is NDC 69168-462?
69168-462 is the product NDC for Dual Action Pain Relief, Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 capsule, listed with the FDA by Allegiant Health. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dual Action Pain Relief.
What is the active ingredient?
Acetaminophen, Ibuprofen.
Who is the labeler?
Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dual Action Pain Relief?
2 other product NDCs are listed under this name. See all Dual Action Pain Relief 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 Dual Action Pain Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dual Action Pain Reliefacetaminophen, ibuprofenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralTIME CAP LABORATORIES, INC.49483-71649483-0716-4949483-0716-75
Dual Action Pain Reliefacetaminophen, ibuprofenIbuprofen 125 mg/1; Acetaminophen 250 mg/1TabletOralTARGET CORPORATION11673-92411673-0924-75

Other NDCs under ANDA 216592

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

FDA NDC Directory listings under ANDA 216592
ProductStrengthForm · routeLabelerProduct NDC
Period Pills by Biikayacetaminophen, ibuprofenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralKai Squared85576-101
Aacetaminophen and Ibuprofenacetaminophen and ibuprofenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralGRANULES USA, INC.69848-588
Acetaminophen and IbuprofenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralRUGBY LABORATORIES0536-1376
Acetaminophen and IbuprofenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralFamily Dollar55319-139
Acetaminophen and Ibuprofen (NSAID)Ibuprofen 125 mg/1; Acetaminophen 250 mg/1TabletOralWal-Mart Stores Inc.79903-931
Acetaminophen and IbuprofenIbuprofen 125 mg/1; Acetaminophen 250 mg/1TabletOralCVS51316-131
Acetaminophen and IbuprofenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralCVS51316-132
Acetaminophen and IbuprofenIbuprofen 125 mg/1; Acetaminophen 250 mg/1TabletOralWAL-MART STORES INC.79903-244
Acetaminophen and IbuprofenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralGranules Pharmaceuticals Inc.70010-131
Acetaminophen and IbuprofenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralWALGREENS0363-9131
Acetaminophen and Ibuprofen Back Painacetaminophen and ibuprofenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralGranules Pharmaceuticals Inc.70010-213
Acetaminophen and IbuprofenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralLEADER/ Cardinal Health 110, Inc.70000-0622
Acetaminophen and Ibuprofen (NSAID)Ibuprofen 125 mg/1; Acetaminophen 250 mg/1TabletOralRITE AID11822-1131
Acetaminophen and Ibuprofen (NSAID)Ibuprofen 125 mg/1; Acetaminophen 250 mg/1TabletOralRETAIL BUSINESS SERVICES,LLC72476-131
AcetaminophenAcetaminophen 250 mg/1; Ibuprofen 125 mg/1TabletOralRAONBIO CORP70038-131

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