Over-the-counter drug · NDA
Advil PM (Diphenhydramine hcl, ibuprofen) NDC 0573-0167
Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1 · Capsule, Liquid filled · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0573-0167-25 | 00573016725 | 1 BOTTLE in 1 CARTON (0573-0167-25) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 20, 2005 | |
| 0573-0167-26 | 00573016726 | 1 BOTTLE in 1 CARTON (0573-0167-26) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 20, 2005 | |
| 0573-0167-43 | 00573016743 | 1 BOTTLE in 1 CARTON (0573-0167-43) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 20, 2005 | |
| 0573-0167-44 | 00573016744 | 1 BOTTLE in 1 CARTON (0573-0167-44) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 20, 2005 | |
| 0573-0167-55 | 00573016755 | 1 BOTTLE in 1 CARTON (0573-0167-55) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 20, 2005 | |
| 0573-0167-56 | 00573016756 | 1 BOTTLE in 1 CARTON (0573-0167-56) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 20, 2005 |
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)
- Advil PM
- Generic name (nonproprietary)
- diphenhydramine hcl, ibuprofen
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1Ibuprofen — 200 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0573
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021393
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0573-0167_57c5339d-4ab8-ce7f-e063-6394a90a75a5SPL ID 57c5339d-4ab8-ce7f-e063-6394a90a75a5SPL set ID 405afdb4-c157-1d88-f232-848063ba4714RxCUI 901814UNII WK2XYI10QM, TC2D6JAD40
- Pharmacologic class
- Histamine-1 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug
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
N400573016725followed by a unit qualifier and the quantityPackage 00573-0167-25. 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 for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Excerpt only. Read the full label for complete information.
About NDC 0573-0167
- What is NDC 0573-0167?
- 0573-0167 is the product NDC for Advil PM, Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Haleon US Holdings LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Advil PM (Diphenhydramine HCl, ibuprofen).
- What is the active ingredient?
- Diphenhydramine hydrochloride, Ibuprofen.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Advil PM?
- 6 other product NDCs are listed under this name. See all Advil PM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Advil PM products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Advil PMdiphenhydramine hcl, ibuprofen | Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Haleon US Holdings LLC | 0573-0148 | 00573-0148-0600573-0148-07 |
| Advil PMibuprofen and diphenhydramine citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-9633 | 66715-9633-03 |
| Advil PMdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, CoatedOral | Navajo Manufacturing Company Inc. | 67751-147 | 67751-0147-0167751-0147-0267751-0147-06 |
| Advil PMibuprofen and diphenhydramine citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-9733 | 66715-9733-0266715-9733-03 |
| Advil PMdiphenhydramine citrate and ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, CoatedOral | Haleon US Holdings LLC | 0573-0164 | 00573-0164-0400573-0164-0500573-0164-08+18 more |
| Advil PMdiphenhydramine citrate and ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, CoatedOral | Select Consumer Group | 85237-1784 | 85237-1784-0185237-1784-0285237-1784-04+2 more |
Other NDCs under NDA 021393
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Advil PMdiphenhydramine hcl, ibuprofen | Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Haleon US Holdings LLC | 0573-0148 |