FDA.reportPublic FDA data

Pharbetol

Product NDC
16103-353
11-digit product format
161030353
Labeler code
16103
Product ID
16103-353_c23d82e7-ab4d-4bda-b63d-cc7f96bb79f6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-09
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16103-353-07e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16103-353-08e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16103-353-11e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16103-353-079bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16103-353-089bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16103-353-119bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Pharbetol
Brand name suffix
Regular strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313782Internal RxNorm lookup
1298830Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0a39957-d918-4125-88f9-0e550b976fa1Available on FDA.report

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
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
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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
16103-353-072026-01-29Drug Facts
16103-353-082026-01-29Drug Facts
16103-353-112026-01-29Drug Facts
16103-353-072023-06-13Drug Facts
16103-353-082023-06-13Drug Facts
16103-353-112023-06-13Drug Facts
16103-353-072023-01-30Drug Facts
16103-353-082023-01-30Drug Facts
16103-353-112023-01-30Drug Facts
16103-353-072021-01-08Drug Facts
16103-353-082021-01-08Drug Facts
16103-353-112021-01-08Drug Facts
16103-353-072020-01-31Drug Facts
16103-353-082020-01-31Drug Facts
16103-353-112020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-353-07PharbetolRegular strength60 in 1 BOTTLE, PLASTICTABLET605
16103-353-07PharbetolRegular strength1 in 1 CARTONTABLET15
16103-353-08PharbetolRegular strength100 in 1 BOTTLE, PLASTICTABLET1005
16103-353-08PharbetolRegular strength1 in 1 CARTONTABLET15
16103-353-11PharbetolRegular strength1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-353-07EA - Each16103-353be19f1cb-5a83-4ab8-a81c-dbc7b6c366b312013-05-02
16103-353-08EA - Each16103-353d0efd342-8f78-4b8b-b2ab-963c13f461bf12013-05-02
16103-353-11EA - Each16103-353239e09b4-a5bc-4312-a3cc-d82250536ba312013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN TABLET [APOTHECA, INC]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPHARBETOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN TABLET [APOTHECA, INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPHARBETOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN TABLET [APOTHECA, INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHARBETOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BPHARBETOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN TABLET [APOTHECA, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHARBETOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TACETAMINOPHEN TABLET [APOTHECA, INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN TABLET [APOTHECA, INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHARBETOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-353PHARBETOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 5 package rows20250101_e0a39957-d918-4125-88f9-0e550b976fa1.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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN4181efc2-d183-410c-b647-233444c57e3216
313782acetaminophen 325 MG Oral TabletSCD4181efc2-d183-410c-b647-233444c57e3216
313782APAP 325 MG Oral TabletSY4181efc2-d183-410c-b647-233444c57e3216
313782acetaminophen 325 MG Oral TabletPSN471180ea-1b58-436e-ab7a-ed0b88cc460612
1298830Pharbetol Regular Strength 325 MG Oral TabletPSN471180ea-1b58-436e-ab7a-ed0b88cc460612
1298830acetaminophen 325 MG Oral Tablet [Pharbetol]SBD471180ea-1b58-436e-ab7a-ed0b88cc460612
313782acetaminophen 325 MG Oral TabletSCD471180ea-1b58-436e-ab7a-ed0b88cc460612
313782APAP 325 MG Oral TabletSY471180ea-1b58-436e-ab7a-ed0b88cc460612
1298830APAP 325 MG Oral Tablet [Pharbetol]SY471180ea-1b58-436e-ab7a-ed0b88cc460612
1298830Pharbetol 325 MG Oral TabletSY471180ea-1b58-436e-ab7a-ed0b88cc460612
313782acetaminophen 325 MG Oral TabletPSN8cdbe98a-a6ce-4209-9c09-448f800f1d467
1298830Pharbetol Regular Strength 325 MG Oral TabletPSN8cdbe98a-a6ce-4209-9c09-448f800f1d467
1298830acetaminophen 325 MG Oral Tablet [Pharbetol]SBD8cdbe98a-a6ce-4209-9c09-448f800f1d467
313782acetaminophen 325 MG Oral TabletSCD8cdbe98a-a6ce-4209-9c09-448f800f1d467
313782APAP 325 MG Oral TabletSY8cdbe98a-a6ce-4209-9c09-448f800f1d467
1298830APAP 325 MG Oral Tablet [Pharbetol]SY8cdbe98a-a6ce-4209-9c09-448f800f1d467
1298830Pharbetol 325 MG Oral TabletSY8cdbe98a-a6ce-4209-9c09-448f800f1d467
313782acetaminophen 325 MG Oral TabletPSNe0a39957-d918-4125-88f9-0e550b976fa15
1298830Pharbetol Regular Strength 325 MG Oral TabletPSNe0a39957-d918-4125-88f9-0e550b976fa15
1298830acetaminophen 325 MG Oral Tablet [Pharbetol]SBDe0a39957-d918-4125-88f9-0e550b976fa15
313782acetaminophen 325 MG Oral TabletSCDe0a39957-d918-4125-88f9-0e550b976fa15
313782APAP 325 MG Oral TabletSYe0a39957-d918-4125-88f9-0e550b976fa15
1298830APAP 325 MG Oral Tablet [Pharbetol]SYe0a39957-d918-4125-88f9-0e550b976fa15
1298830Pharbetol 325 MG Oral TabletSYe0a39957-d918-4125-88f9-0e550b976fa15
313782acetaminophen 325 MG Oral TabletPSN05a91d24-b498-4ba2-a275-68b871cf62d23
313782acetaminophen 325 MG Oral TabletPSN57e5fc8c-8d69-a36d-e053-2a91aa0af9493
1298830Pharbetol Regular Strength 325 MG Oral TabletPSN05a91d24-b498-4ba2-a275-68b871cf62d23
1298830Pharbetol Regular Strength 325 MG Oral TabletPSN57e5fc8c-8d69-a36d-e053-2a91aa0af9493
1298830acetaminophen 325 MG Oral Tablet [Pharbetol]SBD57e5fc8c-8d69-a36d-e053-2a91aa0af9493
1298830acetaminophen 325 MG Oral Tablet [Pharbetol]SBD05a91d24-b498-4ba2-a275-68b871cf62d23
313782acetaminophen 325 MG Oral TabletSCD57e5fc8c-8d69-a36d-e053-2a91aa0af9493
313782acetaminophen 325 MG Oral TabletSCD05a91d24-b498-4ba2-a275-68b871cf62d23
313782APAP 325 MG Oral TabletSY57e5fc8c-8d69-a36d-e053-2a91aa0af9493
313782APAP 325 MG Oral TabletSY05a91d24-b498-4ba2-a275-68b871cf62d23
1298830APAP 325 MG Oral Tablet [Pharbetol]SY05a91d24-b498-4ba2-a275-68b871cf62d23
1298830APAP 325 MG Oral Tablet [Pharbetol]SY57e5fc8c-8d69-a36d-e053-2a91aa0af9493
1298830Pharbetol 325 MG Oral TabletSY05a91d24-b498-4ba2-a275-68b871cf62d23
1298830Pharbetol 325 MG Oral TabletSY57e5fc8c-8d69-a36d-e053-2a91aa0af9493
313782acetaminophen 325 MG Oral TabletPSN71aa1a99-6e7c-4bfb-97f2-812ab1a68b942
1298830Pharbetol Regular Strength 325 MG Oral TabletPSN71aa1a99-6e7c-4bfb-97f2-812ab1a68b942
1298830acetaminophen 325 MG Oral Tablet [Pharbetol]SBD71aa1a99-6e7c-4bfb-97f2-812ab1a68b942
313782acetaminophen 325 MG Oral TabletSCD71aa1a99-6e7c-4bfb-97f2-812ab1a68b942
313782APAP 325 MG Oral TabletSY71aa1a99-6e7c-4bfb-97f2-812ab1a68b942
1298830APAP 325 MG Oral Tablet [Pharbetol]SY71aa1a99-6e7c-4bfb-97f2-812ab1a68b942
1298830Pharbetol 325 MG Oral TabletSY71aa1a99-6e7c-4bfb-97f2-812ab1a68b942
313782acetaminophen 325 MG Oral TabletPSNbd26081c-e81e-42e8-b3da-2813863a51df1
313782acetaminophen 325 MG Oral TabletPSNb8e87809-405f-4e2a-9b42-3ca10c38da131
1298830Pharbetol Regular Strength 325 MG Oral TabletPSNbd26081c-e81e-42e8-b3da-2813863a51df1
1298830acetaminophen 325 MG Oral Tablet [Pharbetol]SBDbd26081c-e81e-42e8-b3da-2813863a51df1
313782acetaminophen 325 MG Oral TabletSCDbd26081c-e81e-42e8-b3da-2813863a51df1
313782acetaminophen 325 MG Oral TabletSCDb8e87809-405f-4e2a-9b42-3ca10c38da131
313782APAP 325 MG Oral TabletSYbd26081c-e81e-42e8-b3da-2813863a51df1
313782APAP 325 MG Oral TabletSYb8e87809-405f-4e2a-9b42-3ca10c38da131
1298830APAP 325 MG Oral Tablet [Pharbetol]SYbd26081c-e81e-42e8-b3da-2813863a51df1
1298830Pharbetol 325 MG Oral TabletSYbd26081c-e81e-42e8-b3da-2813863a51df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16103-353-07161030353071 BOTTLE, PLASTIC in 1 CARTON (16103-353-07) / 60 TABLET in 1 BOTTLE, PLASTIC2007-01-090000-00-00NoNoCurrent
16103-353-08161030353081 BOTTLE, PLASTIC in 1 CARTON (16103-353-08) / 100 TABLET in 1 BOTTLE, PLASTIC2007-01-090000-00-00NoNoCurrent
16103-353-11161030353111000 TABLET in 1 BOTTLE (16103-353-11) 1000 tablet2007-01-090000-00-00NoNoCurrent