FDA.reportPublic FDA data

Pharbetol

Product NDC
16103-376
11-digit product format
161030376
Labeler code
16103
Product ID
16103-376_008cf9fd-c19d-4e32-8386-2b6f62688e3c
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
2006-01-10
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage16103-376-08IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage16103-376-11IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage16103-376-06IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16103-376-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16103-376-11IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16103-376-06IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16103-376-08IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16103-376-11IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16103-376-06IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage16103-376-08EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage16103-376-06EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage16103-376-11EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 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
198440Internal RxNorm lookup
1293942Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
04dbd98f-c74d-43b2-8bda-74f18be7cf6cAvailable 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
16103-376-062024-01-19Pharbetol Extra Stength Tablet
16103-376-082024-01-19Pharbetol Extra Stength Tablet
16103-376-112024-01-19Pharbetol Extra Stength Tablet
16103-376-062022-01-28Pharbetol Extra Stength Tablet
16103-376-082022-01-28Pharbetol Extra Stength Tablet
16103-376-112022-01-28Pharbetol Extra Stength Tablet
16103-376-062020-05-22Pharbetol Extra Stength Tablet
16103-376-082020-05-22Pharbetol Extra Stength Tablet
16103-376-112020-05-22Pharbetol Extra Stength Tablet
16103-376-062020-01-31Pharbetol Extra Stength Tablet
16103-376-082020-01-31Pharbetol Extra Stength Tablet
16103-376-112020-01-31Pharbetol Extra Stength Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-376-06Pharbetol50 in 1 BOTTLE, PLASTICTABLET505
16103-376-06Pharbetol1 in 1 CARTONTABLET15
16103-376-08Pharbetol100 in 1 BOTTLE, PLASTICTABLET1005
16103-376-08Pharbetol1 in 1 CARTONTABLET15
16103-376-11Pharbetol1000 in 1 BOTTLE, PLASTICTABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-376-06EA - Each16103-376b0ec28db-7535-413e-805f-e1416eeca91812012-07-24
16103-376-08EA - Each16103-376b9284189-e1cd-4f69-88be-fb02466b57ca12012-07-24
16103-376-11EA - Each16103-3767d6a6a6a-b98e-44d2-8664-e2351539d62b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-376PHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 5 package rows20250101_04dbd98f-c74d-43b2-8bda-74f18be7cf6c.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 27 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREENS CO.d92d97a8-0ee3-1206-e053-2a95a90a72a82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSAM'S WEST INC0c8e7095-0806-4501-e063-6394a90a89aa2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREEN CO.b3763182-2428-155a-e053-2995a90ab5782025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREENSe467b78e-9f23-5563-e053-2a95a90a586e2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWalgreensfd7c3250-35d4-494a-e053-6394a90a2db52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC1ddb8a2b-3081-3eda-e063-6294a90ab82b2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCb1307d52-10e6-46e1-e053-2995a90a03b62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCc2c6d6a1-b492-506d-e053-2995a90aac232025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
application number: M013
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINNUVICARE LLC3a4aa3c7-b726-4303-8803-74196fa5637a2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
application number: M013
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN64696f65-415e-4ce1-a5b3-70662fbcb00217
198440acetaminophen 500 MG Oral TabletSCD64696f65-415e-4ce1-a5b3-70662fbcb00217
198440APAP 500 MG Oral TabletSY64696f65-415e-4ce1-a5b3-70662fbcb00217
198440acetaminophen 500 MG Oral TabletPSN04dbd98f-c74d-43b2-8bda-74f18be7cf6c5
198440acetaminophen 500 MG Oral TabletPSN51ba690e-d76b-41c6-a083-8bc803e1faa25
1293942Pharbetol 500 MG Oral TabletPSN51ba690e-d76b-41c6-a083-8bc803e1faa25
1293942Pharbetol 500 MG Oral TabletPSN04dbd98f-c74d-43b2-8bda-74f18be7cf6c5
1293942acetaminophen 500 MG Oral Tablet [Pharbetol]SBD04dbd98f-c74d-43b2-8bda-74f18be7cf6c5
1293942acetaminophen 500 MG Oral Tablet [Pharbetol]SBD51ba690e-d76b-41c6-a083-8bc803e1faa25
198440acetaminophen 500 MG Oral TabletSCD04dbd98f-c74d-43b2-8bda-74f18be7cf6c5
198440acetaminophen 500 MG Oral TabletSCD51ba690e-d76b-41c6-a083-8bc803e1faa25
198440APAP 500 MG Oral TabletSY04dbd98f-c74d-43b2-8bda-74f18be7cf6c5
198440APAP 500 MG Oral TabletSY51ba690e-d76b-41c6-a083-8bc803e1faa25
1293942APAP 500 MG Oral Tablet [Pharbetol]SY04dbd98f-c74d-43b2-8bda-74f18be7cf6c5
1293942APAP 500 MG Oral Tablet [Pharbetol]SY51ba690e-d76b-41c6-a083-8bc803e1faa25
1293942Pharbetol 500 MG Oral TabletSY51ba690e-d76b-41c6-a083-8bc803e1faa25
1293942Pharbetol 500 MG Oral TabletSY04dbd98f-c74d-43b2-8bda-74f18be7cf6c5
198440acetaminophen 500 MG Oral TabletPSN19f6c2a4-9969-471b-85ef-f01c56cf92ed2
1293942Pharbetol 500 MG Oral TabletPSN19f6c2a4-9969-471b-85ef-f01c56cf92ed2
1293942acetaminophen 500 MG Oral Tablet [Pharbetol]SBD19f6c2a4-9969-471b-85ef-f01c56cf92ed2
198440acetaminophen 500 MG Oral TabletSCD19f6c2a4-9969-471b-85ef-f01c56cf92ed2
198440APAP 500 MG Oral TabletSY19f6c2a4-9969-471b-85ef-f01c56cf92ed2
1293942APAP 500 MG Oral Tablet [Pharbetol]SY19f6c2a4-9969-471b-85ef-f01c56cf92ed2
1293942Pharbetol 500 MG Oral TabletSY19f6c2a4-9969-471b-85ef-f01c56cf92ed2
198440acetaminophen 500 MG Oral TabletPSN6a70eac1-9947-80a8-e053-2991aa0abfde1
198440acetaminophen 500 MG Oral TabletSCD6a70eac1-9947-80a8-e053-2991aa0abfde1
198440APAP 500 MG Oral TabletSY6a70eac1-9947-80a8-e053-2991aa0abfde1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16103-376-06161030376061 BOTTLE, PLASTIC in 1 CARTON (16103-376-06) / 50 TABLET in 1 BOTTLE, PLASTIC2006-01-100000-00-00NoNoCurrent
16103-376-08161030376081 BOTTLE, PLASTIC in 1 CARTON (16103-376-08) / 100 TABLET in 1 BOTTLE, PLASTIC2006-01-100000-00-00NoNoCurrent
16103-376-11161030376111000 TABLET in 1 BOTTLE, PLASTIC (16103-376-11) 1000 tablet2006-01-100000-00-00NoNoCurrent