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

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 Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui313782, 1298830

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-353-072026-01-29C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-082026-01-29C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-112026-01-29C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-072023-06-13C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-082023-06-13C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-112023-06-13C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-072023-01-30C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-082023-01-30C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-112023-01-30C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-072021-01-08C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-082021-01-08C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-112021-01-08C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-072020-01-31C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-082020-01-31C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug Facts
16103-353-112020-01-31C16284748780-19d75b9cf-d8a4-f424-e053-dadaa90a57ceDrug 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

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