FDA.reportPublic FDA data

ADVIL PM

Product NDC
0573-0164
11-digit product format
005730164
Labeler code
0573
Product ID
0573-0164_15971707-84cd-4742-e063-6394a90af906
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine citrate and ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA021394
Marketing category
NDA
Marketing start
2005-12-21
Substance
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength
38; 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ADVIL PM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE CITRATE38 mg/1
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4OD433S209, WK2XYI10QM
Rxcui895664

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0164-042024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-052024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-082024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-092024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-122024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-142024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-202024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-212024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-302024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-322024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-332024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-402024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-412024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-432024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-442024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-452024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-462024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-492024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-552024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-652024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts
0573-0164-912024-01-31C16284748780-11030e365-34de-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0164-04ADVIL PM4 in 1 POUCHTABLET, COATED421
0573-0164-05ADVIL PM2 in 1 BOTTLETABLET, COATED221
0573-0164-05ADVIL PM2 in 1 CARTONTABLET, COATED221
0573-0164-08ADVIL PM8 in 1 VIALTABLET, COATED821
0573-0164-08ADVIL PM1 in 1 PACKAGETABLET, COATED121
0573-0164-09ADVIL PM8 in 1 VIALTABLET, COATED821
0573-0164-12ADVIL PM2 in 1 POUCHTABLET, COATED221
0573-0164-12ADVIL PM6 in 1 CARTONTABLET, COATED621
0573-0164-14ADVIL PM2 in 1 POUCHTABLET, COATED221
0573-0164-14ADVIL PM2 in 1 CARTONTABLET, COATED221
0573-0164-20ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-20ADVIL PM20 in 1 BOTTLETABLET, COATED2021
0573-0164-21ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-21ADVIL PM30 in 1 BOTTLETABLET, COATED3021
0573-0164-30ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-30ADVIL PM40 in 1 BOTTLETABLET, COATED4021
0573-0164-32ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-32ADVIL PM50 in 1 BOTTLETABLET, COATED5021
0573-0164-33ADVIL PM50 in 1 BOTTLETABLET, COATED5021
0573-0164-33ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-40ADVIL PM80 in 1 BOTTLETABLET, COATED8021
0573-0164-40ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-41ADVIL PM100 in 1 BOTTLETABLET, COATED10021
0573-0164-41ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-43ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-43ADVIL PM120 in 1 BOTTLETABLET, COATED12021
0573-0164-44ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-44ADVIL PM140 in 1 BOTTLETABLET, COATED14021
0573-0164-45ADVIL PM180 in 1 BOTTLETABLET, COATED18021
0573-0164-45ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-46ADVIL PM180 in 1 BOTTLETABLET, COATED18021
0573-0164-46ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-49ADVIL PM1 in 1 CARTONTABLET, COATED121
0573-0164-49ADVIL PM200 in 1 BOTTLETABLET, COATED20021
0573-0164-55ADVIL PM50 in 1 TRAYTABLET, COATED5021
0573-0164-55ADVIL PM2 in 1 POUCHTABLET, COATED221
0573-0164-65ADVIL PM120 in 1 BOTTLETABLET, COATED12021
0573-0164-91ADVIL PM3000 in 1 BOXTABLET, COATED300021
0573-0164-91ADVIL PM2 in 1 POUCHTABLET, COATED221

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0164-05EA - Each0573-016429ee0873-ce1d-488b-945e-8060bb4ccb4a12012-07-24
0573-0164-08EA - Each0573-016461da8eca-12fa-4e21-ad47-a371b3e87f9912022-06-06
0573-0164-12EA - Each0573-016417b84eac-a74d-4ffe-8ac8-3de75c13d8e012019-06-19
0573-0164-14EA - Each0573-0164f1a6b8ef-c28d-4a6d-9a89-98d4e537201512019-06-19
0573-0164-20EA - Each0573-0164e0975540-d483-4aa3-9a5f-a647f2986fcc12012-07-24
0573-0164-30EA - Each0573-0164da7bb72a-9d06-4eb0-b919-d8739362742012012-07-24
0573-0164-40EA - Each0573-0164ad944255-4b0d-4ec7-9f86-47f47e6b9d9112012-07-24
0573-0164-43EA - Each0573-016440258c9f-9173-4c4c-95de-258d67f51a5f12013-08-02
0573-0164-55EA - Each0573-016488938333-f8b2-4a98-8627-645de71706b212014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE CITRATEACTIVE INGREDIENT4OD433S209ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
IBUPROFENACTIVE INGREDIENTWK2XYI10QMADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
IBUPROFENACTIVE MOIETYWK2XYI10QMADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [PFIZER CONSUMER HEALTHCARE]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0164ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [HALEON US HOLDINGS LLC]21Current NDC, Legacy NDC, 39 package rows20240410_658fc201-47c9-6a6d-8af9-6208298d43b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSN658fc201-47c9-6a6d-8af9-6208298d43b421
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCD658fc201-47c9-6a6d-8af9-6208298d43b421
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNa3c30dd2-75f3-4f8b-88d7-4a63dea5bad73
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDa3c30dd2-75f3-4f8b-88d7-4a63dea5bad73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0164-04005730164044 TABLET, COATED in 1 POUCH (0573-0164-04) 2005-12-210000-00-00NoNoCurrent
0573-0164-05005730164052 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE2 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-08005730164081 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIAL1 vial2017-03-170000-00-00NoNoCurrent
0573-0164-09005730164098 TABLET, COATED in 1 VIAL (0573-0164-09) 2017-03-170000-00-00NoNoCurrent
0573-0164-12005730164126 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCH6 pouch2005-12-210000-00-00NoNoCurrent
0573-0164-14005730164142 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCH2 pouch2005-12-210000-00-00NoNoCurrent
0573-0164-20005730164201 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-21005730164211 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-30005730164301 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-32005730164321 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-33005730164331 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-40005730164401 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-41005730164411 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-43005730164431 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-44005730164441 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-45005730164451 BOTTLE in 1 CARTON (0573-0164-45) / 180 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-46005730164461 BOTTLE in 1 CARTON (0573-0164-46) / 180 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-49005730164491 BOTTLE in 1 CARTON (0573-0164-49) / 200 TABLET, COATED in 1 BOTTLE1 bottle2005-12-210000-00-00NoNoCurrent
0573-0164-550057301645550 POUCH in 1 TRAY (0573-0164-55) / 2 TABLET, COATED in 1 POUCH50 pouch2005-12-210000-00-00NoNoCurrent
0573-0164-6500573016465120 TABLET, COATED in 1 BOTTLE (0573-0164-65) 2016-09-300000-00-00NoNoCurrent
0573-0164-91005730164913000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCH3000 pouch2005-12-210000-00-00NoNoCurrent