Acetaminophen and Ibuprofen Back Pain
- Product NDC
- 58602-895
- 11-digit product format
- 586020895
- Labeler code
- 58602
- Product ID
- 58602-895_358fae0b-3a56-4ffa-ba09-de83cd8200a5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA218359
- Marketing category
- ANDA
- Marketing start
- 2024-03-26
- Substance
- ACETAMINOPHEN; IBUPROFEN
- Active strength
- 250; 125 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen and Ibuprofen Back Pain
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/1 |
| IBUPROFEN | 125 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, WK2XYI10QM |
| Rxcui | 2387532 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58602-895-01 | Acetaminophen and Ibuprofen Back Pain | 24 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 24 | 2 | |
| 58602-895-01 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-03 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-03 | Acetaminophen and Ibuprofen Back Pain | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 2 | |
| 58602-895-07 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-07 | Acetaminophen and Ibuprofen Back Pain | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 2 | |
| 58602-895-11 | Acetaminophen and Ibuprofen Back Pain | 36 in 1 BOTTLE | TABLET, FILM COATED | 36 | 2 | |
| 58602-895-11 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-14 | Acetaminophen and Ibuprofen Back Pain | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 2 | |
| 58602-895-14 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-21 | Acetaminophen and Ibuprofen Back Pain | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 2 | |
| 58602-895-21 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-29 | Acetaminophen and Ibuprofen Back Pain | 150 in 1 BOTTLE | TABLET, FILM COATED | 150 | 2 | |
| 58602-895-29 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-35 | Acetaminophen and Ibuprofen Back Pain | 225 in 1 BOTTLE | TABLET, FILM COATED | 225 | 2 | |
| 58602-895-40 | Acetaminophen and Ibuprofen Back Pain | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 2 | |
| 58602-895-41 | Acetaminophen and Ibuprofen Back Pain | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 2 | |
| 58602-895-44 | Acetaminophen and Ibuprofen Back Pain | 400 in 1 BOTTLE | TABLET, FILM COATED | 400 | 2 | |
| 58602-895-46 | Acetaminophen and Ibuprofen Back Pain | 18 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 18 | 2 | |
| 58602-895-46 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-49 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-49 | Acetaminophen and Ibuprofen Back Pain | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | 2 | |
| 58602-895-51 | Acetaminophen and Ibuprofen Back Pain | 216 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 216 | 2 | |
| 58602-895-61 | Acetaminophen and Ibuprofen Back Pain | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 2 | |
| 58602-895-61 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-62 | Acetaminophen and Ibuprofen Back Pain | 216 in 1 BOTTLE | TABLET, FILM COATED | 216 | 2 | |
| 58602-895-65 | Acetaminophen and Ibuprofen Back Pain | 72 in 1 BOTTLE | TABLET, FILM COATED | 72 | 2 | |
| 58602-895-65 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-73 | Acetaminophen and Ibuprofen Back Pain | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 2 | |
| 58602-895-73 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-78 | Acetaminophen and Ibuprofen Back Pain | 50 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 50 | 2 | |
| 58602-895-78 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-79 | Acetaminophen and Ibuprofen Back Pain | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | 2 | |
| 58602-895-80 | Acetaminophen and Ibuprofen Back Pain | 72 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 72 | 2 | |
| 58602-895-80 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-82 | Acetaminophen and Ibuprofen Back Pain | 18 in 1 BOTTLE | TABLET, FILM COATED | 18 | 2 | |
| 58602-895-82 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-84 | Acetaminophen and Ibuprofen Back Pain | 225 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 225 | 2 | |
| 58602-895-85 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-85 | Acetaminophen and Ibuprofen Back Pain | 36 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 36 | 2 | |
| 58602-895-88 | Acetaminophen and Ibuprofen Back Pain | 750 in 1 BOTTLE | TABLET, FILM COATED | 750 | 2 | |
| 58602-895-94 | Acetaminophen and Ibuprofen Back Pain | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 2 | |
| 58602-895-94 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-95 | Acetaminophen and Ibuprofen Back Pain | 750 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 750 | 2 | |
| 58602-895-96 | Acetaminophen and Ibuprofen Back Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 2 | |
| 58602-895-96 | Acetaminophen and Ibuprofen Back Pain | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | 2 | |
| 58602-895-99 | Acetaminophen and Ibuprofen Back Pain | 400 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 400 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2387532 | acetaminophen 250 MG / ibuprofen 125 MG Oral Tablet | PSN | 62d7ce90-63a4-4383-87c9-3a458eac29bf | 2 |
| 2387532 | acetaminophen 250 MG / ibuprofen 125 MG Oral Tablet | SCD | 62d7ce90-63a4-4383-87c9-3a458eac29bf | 2 |
| 2387532 | APAP 250 MG / ibuprofen 125 MG Oral Tablet | SY | 62d7ce90-63a4-4383-87c9-3a458eac29bf | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58602-895-01 | 58602089501 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2024-03-26 | No | No | Historical | |
| 58602-895-03 | 58602089503 | 1 BOTTLE in 1 CARTON (58602-895-03) / 10 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-26 | No | No | Historical |
| 58602-895-07 | 58602089507 | 1 BOTTLE in 1 CARTON (58602-895-07) / 24 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-26 | No | No | Historical |
| 58602-895-11 | 58602089511 | 1 BOTTLE in 1 CARTON (58602-895-11) / 36 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-26 | No | No | Historical |
| 58602-895-14 | 58602089514 | 1 BOTTLE in 1 CARTON (58602-895-14) / 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-26 | No | No | Historical |
| 58602-895-21 | 58602089521 | 1 BOTTLE in 1 CARTON (58602-895-21) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-26 | No | No | Historical |
| 58602-895-29 | 58602089529 | 1 BOTTLE in 1 CARTON (58602-895-29) / 150 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-26 | No | No | Historical |
| 58602-895-35 | 58602089535 | 225 TABLET, FILM COATED in 1 BOTTLE (58602-895-35) | 2024-03-26 | No | No | Historical | |
| 58602-895-40 | 58602089540 | 500 TABLET, FILM COATED in 1 BOTTLE (58602-895-40) | 2024-03-26 | No | No | Historical | |
| 58602-895-41 | 58602089541 | 1000 TABLET, FILM COATED in 1 BOTTLE (58602-895-41) | 2024-03-26 | No | No | Historical | |
| 58602-895-44 | 58602089544 | 400 TABLET, FILM COATED in 1 BOTTLE (58602-895-44) | 2024-03-26 | No | No | Historical | |
| 58602-895-46 | 58602089546 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-46) / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2024-03-26 | No | No | Historical | |
| 58602-895-49 | 58602089549 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-49) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2024-03-26 | No | No | Historical | |
| 58602-895-51 | 58602089551 | 216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-51) | 2024-03-26 | No | No | Historical | |
| 58602-895-61 | 58602089561 | 1 BLISTER PACK in 1 CARTON (58602-895-61) / 2 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2024-03-26 | No | No | Historical |
| 58602-895-62 | 58602089562 | 216 TABLET, FILM COATED in 1 BOTTLE (58602-895-62) | 2024-03-26 | No | No | Historical | |
| 58602-895-65 | 58602089565 | 1 BOTTLE in 1 CARTON (58602-895-65) / 72 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-26 | No | No | Historical |
| 58602-895-73 | 58602089573 | 1 BOTTLE in 1 CARTON (58602-895-73) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-26 | No | No | Historical |
| 58602-895-78 | 58602089578 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-78) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2024-03-26 | No | No | Historical | |
| 58602-895-79 | 58602089579 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-79) | 2024-03-26 | No | No | Historical | |
| 58602-895-80 | 58602089580 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-80) / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2024-03-26 | No | No | Historical | |
| 58602-895-82 | 58602089582 | 1 BOTTLE in 1 CARTON (58602-895-82) / 18 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-03-26 | No | No | Historical |
| 58602-895-84 | 58602089584 | 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-84) | 2024-03-26 | No | No | Historical | |
| 58602-895-85 | 58602089585 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2024-03-26 | No | No | Historical | |
| 58602-895-88 | 58602089588 | 750 TABLET, FILM COATED in 1 BOTTLE (58602-895-88) | 2024-03-26 | No | No | Historical | |
| 58602-895-94 | 58602089594 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-94) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2024-03-26 | No | No | Historical | |
| 58602-895-95 | 58602089595 | 750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-95) | 2024-03-26 | No | No | Historical | |
| 58602-895-96 | 58602089596 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-96) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2024-03-26 | No | No | Historical | |
| 58602-895-99 | 58602089599 | 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-99) | 2024-03-26 | No | No | Historical |