foster and thrive anti diarrheal anti gas

Product NDC
70677-1105
11-digit product format
706771105
Labeler code
70677
Product ID
70677-1105_6707ae05-6e99-4e0a-a1a9-8191e2a45983
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA209837
Marketing category
ANDA
Marketing start
2023-10-31
Substance
DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Active strength
125; 2 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
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 42.

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
A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053f01610625f2…
2019-09-15 20:21 UTC2019-09A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209837-001LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE2MG;125MGTABLET / ORAL2018-09-05e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
foster and thrive anti diarrheal anti gas
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE125 mg/1
DIMETHICONE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
77TI35393CInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
978001Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9132dc1c-8e16-4236-881e-863f5e57f0abAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1105-1foster and thrive anti diarrheal anti gas12 in 1 CARTONTABLET123
70677-1105-1foster and thrive anti diarrheal anti gas1 in 1 BLISTER PACKTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1105-1EA - Each70677-1105806a9528-7aed-414f-8ad2-78d86518fd9f12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1105FOSTER AND THRIVE ANTI DIARRHEAL ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 2 package rows20240709_9132dc1c-8e16-4236-881e-863f5e57f0ab.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Company2cda08a8-3f5e-430c-84a3-d29b97d647af2026-05-20WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
CareOne Diarrhea and Gas ControlLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmerican Sales Companydfa3db5a-cef6-4ed5-b9f1-a20b6d1657b32026-04-21WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEHyVee Inc396ea4f5-5c3d-4cbc-acd5-09eb64c806e02026-03-02WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEH E B35cff261-932e-4b2e-ab21-80969c27fa922025-06-27WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
good neighbor pharmacy anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmerisource Bergen5dae1247-3ec0-495e-b3f2-1c15551416172025-04-08WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
Anti Diarrheal Anti GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEKroger Company9c7db942-c8cb-493a-a96f-452b8dfebfc62024-07-23WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
signature care anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONESafeway53829e72-d22c-434d-a108-1972081a6efb2024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEWalgreen Company0999243a-c3be-41a6-b327-962e63d8c3562024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
dg health anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDolgencorp, LLC09798231-39cd-49b2-9be5-ea51e52f0a6d2024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
Basic Care Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmazon.com Services LLCaa79234e-1fbd-4279-b4b1-46b4f041b4e82024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
equaline anti diarrheal plus anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEUnited Natural Foods, Inc. dba UNFI2ce0b37e-6dc4-423f-a1d6-a2cb623946d52024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
up and up anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONETarget Corporationef75085c-95df-4901-9c97-069fcfc3eef72024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872024-07-22WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332024-07-20WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
Good Sense Anti Diarrheal Anti GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Companyfcfd0b64-6876-4e6f-8a7b-ca1da9e03f002024-07-13WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
anti diarrheal plus anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEMeijer Distribution Ince2c9a752-618a-4e34-89a5-671aab4013ac2024-07-11WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
foster and thrive anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEStrategic Sourcing Services LLC9132dc1c-8e16-4236-881e-863f5e57f0ab2024-07-08WarningsExact identifier
application applno (ANDA): 209837
application number: ANDA209837
ndc (product): 70677-1105

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN9132dc1c-8e16-4236-881e-863f5e57f0ab3
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD9132dc1c-8e16-4236-881e-863f5e57f0ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1105-17067711050112 BLISTER PACK in 1 CARTON (70677-1105-1) / 1 TABLET in 1 BLISTER PACK12 blister pack2023-10-31NoNoCurrent