ADVIL PM

Product NDC
0573-0167
11-digit product format
005730167
Labeler code
0573
Product ID
0573-0167_57c5339d-4ab8-ce7f-e063-6394a90a75a5
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine HCl, ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA021393
Marketing category
NDA
Marketing start
2005-12-20
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active strength
25; 200 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0573-01670573-0167-10DDiscontinued by firm2026-10-05
excluded packagepackage0573-01670573-0167-18DDiscontinued by firm2026-10-05
excluded packagepackage0573-01670573-0167-19DDiscontinued by firm2026-10-05
excluded packagepackage0573-01670573-0167-20DDiscontinued by firm2026-10-05
excluded packagepackage0573-01670573-0167-21DDiscontinued by firm2026-10-05
excluded packagepackage0573-01670573-0167-42DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050573-0167-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050573-0167-19d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050573-0167-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050573-0167-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050573-0167-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050573-0167-18d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260573-0167-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260573-0167-19f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260573-0167-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260573-0167-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260573-0167-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260573-0167-18f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310573-0167-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310573-0167-192ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310573-0167-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310573-0167-422ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310573-0167-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310573-0167-182ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280573-0167-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280573-0167-19a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280573-0167-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280573-0167-42a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280573-0167-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280573-0167-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210573-0167-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210573-0167-19cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210573-0167-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210573-0167-42cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210573-0167-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210573-0167-18cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100573-0167-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100573-0167-19cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100573-0167-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100573-0167-42cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100573-0167-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100573-0167-18cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310573-0167-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310573-0167-19302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310573-0167-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310573-0167-42302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310573-0167-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310573-0167-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200573-0167-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200573-0167-19ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200573-0167-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200573-0167-42ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200573-0167-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200573-0167-18ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100573-0167-420efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100573-0167-210efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100573-0167-180efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100573-0167-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100573-0167-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100573-0167-190efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080573-0167-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080573-0167-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080573-0167-21ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080573-0167-18ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080573-0167-42ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080573-0167-19ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021393-001ADVIL PMDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2184e616aacf4f…
2026-08-18 06:07:402026-07N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021393-00188838492022-01-17U-16182014-12-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021393-00191557182022-01-17Drug product2015-11-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021393-00188838492022-01-17U-16182014-12-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021393-00191557182022-01-17Drug product2015-11-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021393-00188838492022-01-17U-16182014-12-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021393-00191557182022-01-17Drug product2015-11-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021393-00188838492022-01-17U-16182014-12-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021393-00191557182022-01-17Drug product2015-11-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021393-00188838492022-01-17U-16182014-12-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021393-00191557182022-01-17Drug product2015-11-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021393-00188838492022-01-17U-16182014-12-09782e0a99824c…
2021-12-28 21:50 UTC2021-12N021393-00191557182022-01-17Drug product2015-11-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021393-00188838492022-01-17U-16182014-12-0987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021393-00191557182022-01-17Drug product2015-11-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N021393-00188838492022-01-17U-16182014-12-095aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021393-00191557182022-01-17Drug product2015-11-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021393-00188838492022-01-17U-16182014-12-098869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021393-00191557182022-01-17Drug product2015-11-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021393-00188838492022-01-17U-16182014-12-09c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021393-00191557182022-01-17Drug product2015-11-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021393-00188838492022-01-17U-16182014-12-093f01610625f2…
2019-12-14 00:12 UTC2019-12N021393-00191557182022-01-17Drug product2015-11-103f01610625f2…
2019-09-15 20:21 UTC2019-09N021393-00188838492022-01-17U-16182014-12-09b00525d2431f…
2019-09-15 20:21 UTC2019-09N021393-00191557182022-01-17Drug product2015-11-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N021393-00188838492022-01-17U-16182014-12-09ea99ee380514…
2019-07-19 19:46 UTC2019-07N021393-00191557182022-01-17Drug product2015-11-10ea99ee380514…
2023-01-26 05:58 UTC2023-01N021393-00188838492022-01-17U-16182014-12-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021393-00191557182022-01-17Drug product2015-11-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021393-00188838492022-01-17U-16182014-12-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021393-00191557182022-01-17Drug product2015-11-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021393-00188838492022-01-17U-16182014-12-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021393-00191557182022-01-17Drug product2015-11-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021393-00188838492022-01-17U-16182014-12-09e64feba35796…
2022-09-29 23:25 UTC2022-09N021393-00191557182022-01-17Drug product2015-11-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021393-00188838492022-01-17U-16182014-12-09cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021393-00191557182022-01-17Drug product2015-11-10cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ADVIL PM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
IBUPROFEN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
901814Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
405afdb4-c157-1d88-f232-848063ba4714Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0167-10ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-10ADVIL PM16 in 1 CARTONCAPSULE, LIQUID FILLED1621
0573-0167-18ADVIL PM24 in 1 CARTONCAPSULE, LIQUID FILLED2421
0573-0167-18ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-19ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-19ADVIL PM24 in 1 CARTONCAPSULE, LIQUID FILLED2421
0573-0167-20ADVIL PM32 in 1 CARTONCAPSULE, LIQUID FILLED3221
0573-0167-20ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-21ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-21ADVIL PM40 in 1 CARTONCAPSULE, LIQUID FILLED4021
0573-0167-25ADVIL PM20 in 1 BOTTLECAPSULE, LIQUID FILLED2021
0573-0167-25ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121
0573-0167-26ADVIL PM30 in 1 BOTTLECAPSULE, LIQUID FILLED3021
0573-0167-26ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121
0573-0167-42ADVIL PM40 in 1 CARTONCAPSULE, LIQUID FILLED4021
0573-0167-42ADVIL PM1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
0573-0167-43ADVIL PM40 in 1 BOTTLECAPSULE, LIQUID FILLED4021
0573-0167-43ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121
0573-0167-44ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121
0573-0167-44ADVIL PM50 in 1 BOTTLECAPSULE, LIQUID FILLED5021
0573-0167-55ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121
0573-0167-55ADVIL PM80 in 1 BOTTLECAPSULE, LIQUID FILLED8021
0573-0167-56ADVIL PM100 in 1 BOTTLECAPSULE, LIQUID FILLED10021
0573-0167-56ADVIL PM1 in 1 CARTONCAPSULE, LIQUID FILLED121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0167-10EA - Each0573-0167215fd11c-a5f8-40b6-8e00-0762da413c3c12014-01-04
0573-0167-20EA - Each0573-016702755d54-e1de-4282-b019-343a7ef4ea1212012-07-24
0573-0167-25EA - Each0573-01675c48509c-cd84-4810-846a-2222b554326612015-04-03
0573-0167-43EA - Each0573-016708c315ed-78d2-495c-9542-7e0676410f6a12015-01-05
0573-0167-55EA - Each0573-0167902635c1-b011-4bd5-a3c3-c40426075af012015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
IBUPROFENACTIVE INGREDIENTWK2XYI10QMADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
GELATININACTIVE INGREDIENT2G86QN327LADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
SORBITANINACTIVE INGREDIENT6O92ICV9RUADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
SORBITOLINACTIVE INGREDIENT506T60A25RADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10
WATERINACTIVE INGREDIENT059QF0KO0RADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [PFIZER CONSUMER HEALTHCARE]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0167ADVIL PM (DIPHENHYDRAMINE HCL, IBUPROFEN) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]21Current NDC, Legacy NDC, 24 package rows20250117_405afdb4-c157-1d88-f232-848063ba4714.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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL PMDIPHENHYDRAMINE HCL, IBUPROFENHaleon US Holdings LLC405afdb4-c157-1d88-f232-848063ba47142026-07-29WarningsExact identifier
application applno (NDA): 021393
application number: NDA021393
ndc (product): 0573-0167

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901814ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral CapsulePSN405afdb4-c157-1d88-f232-848063ba471421
901814diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral CapsuleSCD405afdb4-c157-1d88-f232-848063ba471421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0167-10005730167101 in 1 BLISTER PACKHistorical
0573-0167-180057301671824 in 1 CARTONHistorical
0573-0167-19005730167191 in 1 BLISTER PACKHistorical
0573-0167-200057301672032 in 1 CARTONHistorical
0573-0167-21005730167211 in 1 BLISTER PACKHistorical
0573-0167-25005730167251 BOTTLE in 1 CARTON (0573-0167-25) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent
0573-0167-26005730167261 BOTTLE in 1 CARTON (0573-0167-26) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent
0573-0167-420057301674240 in 1 CARTONHistorical
0573-0167-43005730167431 BOTTLE in 1 CARTON (0573-0167-43) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent
0573-0167-44005730167441 BOTTLE in 1 CARTON (0573-0167-44) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent
0573-0167-55005730167551 BOTTLE in 1 CARTON (0573-0167-55) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent
0573-0167-56005730167561 BOTTLE in 1 CARTON (0573-0167-56) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2005-12-200000-00-00NoNoCurrent