FDA.reportPublic FDA data

SurviveX Travel Med Kit

Manufacturer
Intent Brands LLC
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:46

Label at a glance#

ProductSurviveX Travel Med Kit
Active ingredientLOPERAMIDE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, LORATADINE, MECLIZINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, ACETAMINOPHEN, ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE, BISMUTH SUBSALICYLATE, CALCIUM CARBONATE
Label structure7 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

Please see outer packaging and individual inserts for full drug facts.

DOSAGE & ADMINISTRATION SECTION

Please see outer packaging and individual inserts for full drug facts.

INDICATIONS & USAGE SECTION

Please see outer packaging and individual inserts for full drug facts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Please see outer packaging and individual inserts for full drug facts.

OTC - PURPOSE SECTION

Please see outer packaging and individual inserts for full drug facts.

INACTIVE INGREDIENT SECTION

None

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging Front

Packaging_FrontPackaging_Front

Packaging Back
Packaging BackPackaging Back

Insert Front

Insert FrontInsert Front

Insert Back

Insert BackInsert Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN1
153008Advil 200 MG Oral TabletPSN1
1536680Alka-Seltzer 325 MG / 1000 MG / 1916 MG Effervescent Oral TabletPSN1
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSN1
212033aspirin 325 MG Oral TabletPSN1
308761bismuth subsalicylate 262 MG Chewable TabletPSN1
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN1
978012Diamode 2 MG Oral TabletPSN1
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
310965ibuprofen 200 MG Oral TabletPSN1
978010loperamide HCl 2 MG Oral TabletPSN1
1020126Loradamed 10 MG 24HR Oral TabletPSN1
311372loratadine 10 MG 24HR Oral TabletPSN1
995666meclizine HCl 25 MG Oral TabletPSN1
211151Pepto-Bismol 262 MG Chewable TabletPSN1
1049182phenylephrine HCl 10 MG Oral TabletPSN1
1536680aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SBD1
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD1
153008ibuprofen 200 MG Oral Tablet [Advil]SBD1
978012loperamide hydrochloride 2 MG Oral Tablet [Diamode]SBD1
1020126loratadine 10 MG Oral Tablet [Loradamed]SBD1
313782acetaminophen 325 MG Oral TabletSCD1
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD1
212033aspirin 325 MG Oral TabletSCD1
308761bismuth subsalicylate 262 MG Chewable TabletSCD1
313884calcium carbonate 420 MG Chewable TabletSCD1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1
310965ibuprofen 200 MG Oral TabletSCD1
978010loperamide hydrochloride 2 MG Oral TabletSCD1
311372loratadine 10 MG Oral TabletSCD1
995666meclizine hydrochloride 25 MG Oral TabletSCD1
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD1
153008Advil 200 MG Oral TabletSY1
1536680Alka-Seltzer (aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG) Effervescent Oral TabletSY1
313782APAP 325 MG Oral TabletSY1
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY1
1536680ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SY1
212033ASA 325 MG Oral TabletSY1
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY1
978012Diamode 2 MG Oral TabletSY1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1
1020126Loradamed 10 MG Oral TabletSY1
311372loratadine 10 MG 24 HR Oral TabletSY1
211151Pepto-bismol 262 MG Chewable TabletSY1
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSY1
211151Pepto-Bismol To-Go 262 MG Chewable TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
LOPERAMIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MECLIZINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850056038997GTIN-13: 0850056038997
EAN-13: 0850056038997
GTIN-12: 850056038997
UPC-A: 850056038997
GTIN storage (14 digits): 00850056038997		87625-100-01_Packaging_Back.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
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874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
377068df-225f-7318-a910-a1987cdfa361Product name320170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87625-100-01SurviveX Travel Med Kit1 in 1 KITKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-200-33EA - Each47682-200f07bc0d3-2ced-4052-ba14-126376ba97df12012-07-24
47682-200-50EA - Each47682-2001792fba4-32e7-461b-9844-385042675db512012-07-24
47682-200-64EA - Each47682-20094aca123-bb93-43e6-bf00-3c3df07db82a12023-08-08
47682-200-69EA - Each47682-20080247ac0-4431-4ac1-893d-7b7a9a0347e912012-07-24
47682-809-13EA - Each47682-809b5402442-85bd-4831-a588-735509ab91c012012-07-24
47682-809-33EA - Each47682-8090d070cb2-2a01-40e4-86c2-9eda62926fb512012-07-24
47682-809-48EA - Each47682-80946394f23-1b9c-4b7e-9be9-7384d321ba6f12012-07-24
47682-809-64EA - Each47682-8091421e68b-bfec-4e77-8e04-52280e5d304612013-03-03
47682-203-12EA - Each47682-2035c75ae27-7ce9-4d53-a9bc-1b7d1b3fd62b12017-04-05
47682-203-50EA - Each47682-20320e3c3a0-a4c5-4e78-84ad-01463719a1ec12012-07-24
0573-0151-10EA - Each0573-0151c22c2b62-cb1b-47da-905a-c1d2baa57ee312012-07-24
0573-0151-12EA - Each0573-01515e6d3dd3-a726-4630-8369-b574dda5d63312014-01-04
0573-0151-13EA - Each0573-0151e7d5d93e-6114-42d0-960f-6fc4c00b8c3e12012-07-24
0573-0151-20EA - Each0573-0151dc114b62-9cd7-41d3-abb4-2f60dc6a0b9f12019-06-19
0573-0151-21EA - Each0573-01514022da23-2508-4765-a9c9-498bd6e7191912025-01-14
0573-0151-30EA - Each0573-0151b5c5d903-a312-464f-899e-495af67994c012025-01-14
0573-0151-40EA - Each0573-0151a96abd80-509c-4f05-ad10-58f7a272858c12025-08-11
47682-803-13EA - Each47682-80369053d1e-b259-4b5f-acef-863753677b3012012-07-24
47682-803-33EA - Each47682-8036ce7f5f9-a8ad-46aa-99c7-b186bf154ad712012-07-24
47682-803-48EA - Each47682-803a94b0390-13d0-4b1c-a159-24abff09e0bb12012-07-24
47682-803-99EA - Each47682-803a3e93432-20eb-4fdf-a9cf-ff2be36d91c412022-06-06
0280-4000-01EA - Each0280-400032606689-6c79-4060-a9aa-b58911c4183512018-04-19
0280-4000-02EA - Each0280-40007141eb74-1de3-4c07-882b-ff231c88e67812017-05-03
0280-4000-03EA - Each0280-400083b8a0a2-63fb-4d7c-bdb3-6bda6370195e12017-05-03
0280-4000-04EA - Each0280-4000ef6e7000-3638-400e-bf65-9c8c723a2c7d12015-01-05
0280-4000-07EA - Each0280-40003e60255b-47dc-4405-a1c5-3fa19568008b12018-03-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87625-10087625-100-01
87625-107
47682-200
87625-109
47682-809
87625-110
47682-203
87625-108
47682-481
87625-111
47682-167
87625-101
0573-0151
87625-102
47682-803
87625-103
47682-617
87625-106
0280-4000
87625-104
58933-011
87625-105
47682-820

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
LOPERAMIDE HYDROCHLORIDE77TI35393CACTIB
STARCH, CORNO8232NY3SJIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
LACTOSEJ2B2A4N98GIACT
LORATADINE7AJO3BO7QNACTIB
STARCH, CORNO8232NY3SJIACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
STARCH, CORNO8232NY3SJIACT
LACTOSEJ2B2A4N98GIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
IBUPROFENWK2XYI10QMACTIB
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
STARCH, CORNO8232NY3SJIACT
ASPIRINR16CO5Y76EACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLACTIB
ASPIRINR16CO5Y76EACTIB
SODIUM BICARBONATE8MDF5V39QOACTIB
CALCIUM CARBONATEH0G9379FGKIACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
MALTODEXTRIN7CVR7L4A2DIACT
CALCIUM CARBONATEH0G9379FGKACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 3 matching rows.

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
A074091-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10

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 22:38:342026-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1084e616aacf4f…
2026-08-18 06:07:402026-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074091-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL1992-12-10f41ea6bd6efb…

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
A076134-001LORATADINELORATADINE10MGTABLET / ORAL2003-08-18

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 22:38:342026-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1884e616aacf4f…
2026-08-18 06:07:402026-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18f41ea6bd6efb…

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
N018989-001ADVILIBUPROFEN200MGTABLET / ORALRLD, RS1984-05-18

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 22:38:342026-08N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1884e616aacf4f…
2026-08-18 06:07:402026-07N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018989-001ADVIL200MGTABLET / ORAL1984-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018989-001ADVIL200MGTABLET / ORAL1984-05-183f01610625f2…
2019-09-15 20:21 UTC2019-09N018989-001ADVIL200MGTABLET / ORAL1984-05-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N018989-001ADVIL200MGTABLET / ORAL1984-05-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18f41ea6bd6efb…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
583a2bec-f271-f7f3-e063-6294a90aa8ec4feee16b-43be-bb71-e063-6394a90af9592026-08-04WarningsExact identifier
spl set id: 4feee16b-43be-bb71-e063-6394a90af959
ADVILIBUPROFENHaleon US Holdings LLC1a665e64-9f30-be37-4a83-38789f1f1e892026-03-12WarningsExact identifier
ndc (product): 0573-0151
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
ndc (product): 0280-4000
Private Label DistributorLOPERAMIDE HCL 2 MGUnifirst First Aid Corporation069e7979-a223-4819-b6cf-ea2731bf156b2025-12-01WarningsExact identifier
ndc (product): 47682-200
Green Guard 24 Hour Allergy ReliefLORATADINEUnifirst First Aid Corporation32092beb-c177-4b6b-afa4-b4b5d64621f42025-11-21WarningsExact identifier
ndc (product): 47682-203
Pepto Bismol CHEWABLESBISMUTH SUBSALICYLATEProcter & Gamble Manufactura S de RL de CV06fce961-5e57-b640-e063-6394a90a9e8a2025-10-01WarningsExact identifier
ndc (product): 58933-011
Medique Medi-MeclizineMECLIZINE HCLUnifirst First Aid Corporationb3fec2df-c41d-0b56-e053-2995a90a35e82025-09-09WarningsExact identifier
ndc (product): 47682-481
Medique Products AspirinASPIRINUnifirst First Aid Corporation9b28fed0-a993-ca72-e053-2995a90ac7fd2025-09-09WarningsExact identifier
ndc (product): 47682-617
Medique AlcalakCALCIUM CARBONATEUnifirst First Aid Corporation60703e3d-52b1-49c4-b4e2-59d96fa09a782025-09-08WarningsExact identifier
ndc (product): 47682-820
Medi-First Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporation9654f5cd-74d7-44a2-9674-666d1e94ffa72025-09-08WarningsExact identifier
ndc (product): 47682-809
Medique DiphenDIPHENHYDRAMINE HYDROCHLORIDEUnifirst First Aid Corporationb61ee2e0-2543-447d-9fc4-23363d46ce042025-09-08WarningsExact identifier
ndc (product): 47682-167
Medique APAPACETAMINOPHENUnifirst First Aid Corporation04805d9c-d959-4870-a185-48b58a8808802025-09-08WarningsExact identifier
ndc (product): 47682-803

Reported adverse events (FAERS/openFDA)#

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