Advil PM, TRAVEL BASIX

Product NDC
66715-6433
11-digit product format
667156433
Labeler code
66715
Product ID
66715-6433_27e68e85-e284-30b9-e063-6394a90aba9b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen and Diphenhydramine citrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
NDA021394
Marketing category
NDA
Marketing start
2022-11-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021394-001ADVIL PMDIPHENHYDRAMINE CITRATE; IBUPROFEN38MG;200MGTABLET / 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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021394-001ADVIL PM38MG;200MGTABLET / ORALRLD, RS2005-12-21cb3db0bc1861…

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 ZIP2022-06N021394-00182636472022-05-30Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021394-00182636472022-05-30Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021394-00182636472022-05-30Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021394-00182636472022-05-30Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021394-00182636472022-05-30Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021394-00182636472022-05-30Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021394-00182636472022-05-30Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N021394-00182636472022-05-30Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021394-00182636472022-05-30Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021394-00182636472022-05-30Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021394-00182636472022-05-30Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021394-00182636472022-05-30Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021394-00182636472022-05-30Drug productea99ee380514…
2023-01-26 05:58 UTC2023-01N021394-00182636472022-05-30Drug product3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021394-00182636472022-05-30Drug product3a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021394-00182636472022-05-30Drug productf41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021394-00182636472022-05-30Drug producte64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021394-00182636472022-05-30Drug productcb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Advil PM, TRAVEL BASIX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN38 mg/1
DIPHENHYDRAMINE CITRATE200 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
4OD433S209Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
895664Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b876bb40-a38b-445a-bc8a-466b3bfe166dAvailable 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66715-6433-22024-01-30C16284748780-11030e365-636a-111a-e063-dadaa90a10e2Advil ® PM Lil' Drug Store ® , TRAVEL BASIX, CVP ® HEALTH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6433-2Advil PM, TRAVEL BASIX2 in 1 POUCHTABLET, COATED212
66715-6433-2Advil PM, TRAVEL BASIX2 in 1 CARTONTABLET, COATED212

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine citrateACTIVE INGREDIENT4OD433S209ADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
IbuprofenACTIVE INGREDIENTWK2XYI10QMADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
DiphenhydramineACTIVE MOIETY8GTS82S83MADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
IbuprofenACTIVE MOIETYWK2XYI10QMADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933ADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
calcium stearateINACTIVE INGREDIENT776XM7047LADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
glyceryl dibehenateINACTIVE INGREDIENTR8WTH25YS2ADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
polydextroseINACTIVE INGREDIENTVH2XOU12IEADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6433ADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED ADVIL PM, TRAVEL BASIX (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED ADVIL PM, CVP HEALTH (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]12Current NDC, 2 package rows20241219_b876bb40-a38b-445a-bc8a-466b3bfe166d.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL PMDIPHENHYDRAMINE CITRATE AND IBUPROFENSelect Consumer Group52c67ae0-707c-851b-e063-6294a90afda42026-05-27WarningsExact identifier
application applno (NDA): 021394
application number: NDA021394
Advil PMDIPHENHYDRAMINE CITRATE, IBUPROFENNavajo Manufacturing Company Inc.a3c30dd2-75f3-4f8b-88d7-4a63dea5bad72026-04-08WarningsExact identifier
application applno (NDA): 021394
application number: NDA021394
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedADVIL PMLil Drug Store Products, Incd1138e15-8ae4-7b49-e053-2995a90a96072024-12-30WarningsExact identifier
application applno (NDA): 021394
application number: NDA021394
Advil PM, TRAVEL BASIXIBUPROFEN AND DIPHENHYDRAMINE CITRATELil' Drug Store Products, Inc.b876bb40-a38b-445a-bc8a-466b3bfe166d2024-11-27WarningsExact identifier
application applno (NDA): 021394
application number: NDA021394
ndc (product): 66715-6433
ADVIL PMDIPHENHYDRAMINE CITRATE AND IBUPROFENHaleon US Holdings LLC658fc201-47c9-6a6d-8af9-6208298d43b42024-04-08WarningsExact identifier
application applno (NDA): 021394
application number: NDA021394

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895664ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral TabletPSNb876bb40-a38b-445a-bc8a-466b3bfe166d12
895664diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral TabletSCDb876bb40-a38b-445a-bc8a-466b3bfe166d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-6433-2667156433022 POUCH in 1 CARTON (66715-6433-2) / 2 TABLET, COATED in 1 POUCH2 pouch2022-11-15NoNoCurrent