Advil Allergy and Congestion Relief
- Product NDC
- 0573-0196
- Requested package NDC
- 0573-0196-02
- 11-digit product format
- 005730196
- Labeler code
- 0573
- Product ID
- 0573-0196_ac233de1-41cf-4ef0-a7b4-30f395c88c1a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- NDA022113
- Marketing category
- NDA
- Marketing start
- 2012-07-23
- Substance
- CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 4; 200; 10 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | |
| N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022113-001 | ADVIL ALLERGY AND CONGESTION RELIEF | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2011-12-21 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022113-002 | ADVIL MULTI-SYMPTOM COLD & FLU | 4MG;200MG;10MG | TABLET / ORAL | RLD, RS | 2017-04-28 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Advil Allergy and Congestion Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CHLORPHENIRAMINE MALEATE | 4 mg/1 |
| IBUPROFEN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| WK2XYI10QM | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1310503 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a6cc97d8-252a-4527-a470-6d9e356342fd | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 0573-0196-01 | 2024-01-31 | Drug Facts |
| 0573-0196-02 | 2024-01-31 | Drug Facts |
| 0573-0196-10 | 2024-01-31 | Drug Facts |
| 0573-0196-20 | 2024-01-31 | Drug Facts |
| 0573-0196-01 | 2024-01-30 | Drug Facts |
| 0573-0196-02 | 2024-01-30 | Drug Facts |
| 0573-0196-10 | 2024-01-30 | Drug Facts |
| 0573-0196-20 | 2024-01-30 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0573-0196-01 | Advil Allergy and Congestion Relief | 50 in 1 TRAY | TABLET, COATED | 50 | 26 | |
| 0573-0196-01 | Advil Allergy and Congestion Relief | 1 in 1 PACKET | TABLET, COATED | 1 | 26 | |
| 0573-0196-02 | Advil Allergy and Congestion Relief | 1 in 1 PACKET | TABLET, COATED | 1 | 26 | |
| 0573-0196-02 | Advil Allergy and Congestion Relief | 2 in 1 CARTON | TABLET, COATED | 2 | 26 | |
| 0573-0196-10 | Advil Allergy and Congestion Relief | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 26 | |
| 0573-0196-10 | Advil Allergy and Congestion Relief | 1 in 1 CARTON | TABLET, COATED | 1 | 26 | |
| 0573-0196-20 | Advil Allergy and Congestion Relief | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 26 | |
| 0573-0196-20 | Advil Allergy and Congestion Relief | 2 in 1 CARTON | TABLET, COATED | 2 | 26 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0573-0196-01 | EA - Each | 0573-0196 | 9d14018e-d877-4eef-85c7-31c9376c8d98 | 1 | 2016-05-16 |
| 0573-0196-10 | EA - Each | 0573-0196 | fd9744d0-f04f-434a-804a-bda9e470cfe0 | 1 | 2013-02-13 |
| 0573-0196-20 | EA - Each | 0573-0196 | cc6b0675-9eef-4bbb-b743-6c202410d3f0 | 1 | 2016-05-16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0573-0196 | ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HALEON US HOLDINGS LLC] | 26 | Current NDC, Legacy NDC, 8 package rows | 20250410_a6cc97d8-252a-4527-a470-6d9e356342fd.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Advil Multi-Symptom Cold and Flu | CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 7671d104-3c5c-4f63-b6b1-6c91c22592f8 | 2025-10-03 | Warnings | 022113 NDA022113 |
| Advil Allergy and Congestion Relief | CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | a6cc97d8-252a-4527-a470-6d9e356342fd | 2025-04-09 | Warnings | 022113 NDA022113 0573-0196-02 0573-0196 00573019602 |
| Advil Allergy and Congestion Relief | CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | d40bf078-ee6f-4c64-9c74-e4e770c150bf | 2023-03-15 | Warnings | 022113 NDA022113 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1310503 | chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral Tablet | PSN | a6cc97d8-252a-4527-a470-6d9e356342fd | 26 |
| 1310503 | chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SCD | a6cc97d8-252a-4527-a470-6d9e356342fd | 26 |
| 1310503 | chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral Tablet | PSN | d40bf078-ee6f-4c64-9c74-e4e770c150bf | 4 |
| 1310503 | chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SCD | d40bf078-ee6f-4c64-9c74-e4e770c150bf | 4 |
| 1310503 | chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral Tablet | PSN | 883fcccb-cc1b-4b31-9649-771264546b13 | 1 |
| 1310503 | chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SCD | 883fcccb-cc1b-4b31-9649-771264546b13 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0573-0196-02 | 00573019602 | 2 PACKET in 1 CARTON (0573-0196-02) / 1 TABLET, COATED in 1 PACKET | 2 packet | 2019-10-01 | 0000-00-00 | No | No | Current |