Over-the-counter drug · NDA
Advil PM (Diphenhydramine citrate and ibuprofen) NDC 0573-0164
Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0573-0164Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00573-0164Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0573-0164-04 | 00573016404 | 4 TABLET, COATED in 1 POUCH (0573-0164-04)Marketed from Dec 21, 2005 | |
| 0573-0164-05 | 00573016405 | 2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-08 | 00573016408 | 1 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIALMarketed from Mar 17, 2017 | |
| 0573-0164-09 | 00573016409 | 8 TABLET, COATED in 1 VIAL (0573-0164-09)Marketed from Mar 17, 2017 | |
| 0573-0164-12 | 00573016412 | 6 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCHMarketed from Dec 21, 2005 | |
| 0573-0164-14 | 00573016414 | 2 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCHMarketed from Dec 21, 2005 | |
| 0573-0164-20 | 00573016420 | 1 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-21 | 00573016421 | 1 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-30 | 00573016430 | 1 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-32 | 00573016432 | 1 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-33 | 00573016433 | 1 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-40 | 00573016440 | 1 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-41 | 00573016441 | 1 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-43 | 00573016443 | 1 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-44 | 00573016444 | 1 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-45 | 00573016445 | 1 BOTTLE in 1 CARTON (0573-0164-45) / 180 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-46 | 00573016446 | 1 BOTTLE in 1 CARTON (0573-0164-46) / 180 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-49 | 00573016449 | 1 BOTTLE in 1 CARTON (0573-0164-49) / 200 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2005 | |
| 0573-0164-55 | 00573016455 | 50 POUCH in 1 TRAY (0573-0164-55) / 2 TABLET, COATED in 1 POUCHMarketed from Dec 21, 2005 | |
| 0573-0164-65 | 00573016465 | 120 TABLET, COATED in 1 BOTTLE (0573-0164-65)Marketed from Sep 30, 2016 | |
| 0573-0164-91 | 00573016491 | 3000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCHMarketed from Dec 21, 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 citrate and ibuprofen
- Active ingredients
- Diphenhydramine citrate — 38 mg/1Ibuprofen — 200 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0573
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021394
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0573-0164_15971707-84cd-4742-e063-6394a90af906SPL ID 15971707-84cd-4742-e063-6394a90af906SPL set ID 658fc201-47c9-6a6d-8af9-6208298d43b4RxCUI 895664UNII 4OD433S209, WK2XYI10QM
- 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
N400573016404followed by a unit qualifier and the quantityPackage 00573-0164-04. 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 0573-0164
- What is NDC 0573-0164?
- 0573-0164 is the product NDC for Advil PM, Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by Haleon US Holdings LLC. It has 21 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Advil PM (Diphenhydramine citrate and ibuprofen).
- What is the active ingredient?
- Diphenhydramine citrate, 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 | Select Consumer Group | 85237-1784 | 85237-1784-0185237-1784-0285237-1784-04+2 more |
| Advil PMdiphenhydramine hcl, ibuprofen | Diphenhydramine hydrochloride 25 mg/1; Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Haleon US Holdings LLC | 0573-0167 | 00573-0167-2500573-0167-2600573-0167-43+3 more |
Other NDCs under NDA 021394
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 PMibuprofen and diphenhydramine citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-9633 |
| ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedadvil pm | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil Drug Store Products, Inc | 29485-6533 |
| ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedadvil pm | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil Drug Store Products, Inc | 29485-7008 |
| Advil PMibuprofen and diphenhydramine citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-9733 |
| Advil PMdiphenhydramine citrate and ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, CoatedOral | Select Consumer Group | 85237-1784 |
| Advil PMdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, CoatedOral | Navajo Manufacturing Company Inc. | 67751-147 |
| Advil PM, TRAVEL BASIXibuprofen and diphenhydramine citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-6433 |
| Advil PM, CVP HEALTHibuprofen and diphenhydramine citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-6533 |