FDA.reportPublic FDA data

Infants Silapap

Product NDC
54838-145
Requested package NDC
54838-145-30
11-digit product format
548380145
Labeler code
54838
Product ID
54838-145_badd004e-0f97-426a-825f-606b3e1ab63e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
Lannett Company, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1997-04-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
80 mg/.8mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54838-14554838-145-30DDiscontinued 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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
377068df-225f-7318-a910-a1987cdfa361Product name320170608
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product 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
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54838-145-15ML - Milliliter54838-1453f4791e7-3734-44b4-bdec-eed360a160c412012-07-24
54838-145-30ML - Milliliter54838-145cf331cd0-d733-4230-b042-1ae69e6529e612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC]14
AcetaminophenACTIVE MOIETY362O9ITL9DINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC]14
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC]14
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC]14
methylparabenINACTIVE INGREDIENTA2I8C7HI9TINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC]14
propylene glycolINACTIVE INGREDIENT6DC9Q167V3INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC]14
saccharin sodium dihydrateINACTIVE INGREDIENTSB8ZUX40TYINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC]14
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC]14
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC]14
waterINACTIVE INGREDIENT059QF0KO0RINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC]14
AcetaminophenACTIVE INGREDIENT362O9ITL9DINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
AcetaminophenACTIVE MOIETY362O9ITL9DINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RINFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238159acetaminophen 500 MG in 5 mL Oral SolutionPSN9dacc307-0f84-4aa6-a0e6-cb99c6669bc12
238159acetaminophen 100 MG/ML Oral SolutionSCD9dacc307-0f84-4aa6-a0e6-cb99c6669bc12
238159acetaminophen 500 MG per 5 ML Oral SolutionSY9dacc307-0f84-4aa6-a0e6-cb99c6669bc12
238159acetaminophen 80 MG per 0.8 ML Oral SolutionSY9dacc307-0f84-4aa6-a0e6-cb99c6669bc12
238159APAP 100 MG/ML Oral SolutionSY9dacc307-0f84-4aa6-a0e6-cb99c6669bc12
238159acetaminophen 500 MG in 5 mL Oral SolutionPSN0924758b-9d8c-490a-a8b3-56b5aee129621
238159acetaminophen 100 MG/ML Oral SolutionSCD0924758b-9d8c-490a-a8b3-56b5aee129621
238159acetaminophen 500 MG per 5 ML Oral SolutionSY0924758b-9d8c-490a-a8b3-56b5aee129621
238159acetaminophen 80 MG per 0.8 ML Oral SolutionSY0924758b-9d8c-490a-a8b3-56b5aee129621
238159APAP 100 MG/ML Oral SolutionSY0924758b-9d8c-490a-a8b3-56b5aee129621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54838-145-305483801453030 mL in 1 BOTTLE, DROPPER (54838-145-30) 30 ml1997-04-010000-00-00NoNoCurrent