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 date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16103-376-08	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16103-376-11	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16103-376-06	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16103-376-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16103-376-11	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16103-376-06	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16103-376-08	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16103-376-11	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16103-376-06	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	16103-376-08	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	16103-376-06	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	16103-376-11	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`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
Ingredient	Strength
ACETAMINOPHEN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198440	Internal RxNorm lookup
1293942	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
04dbd98f-c74d-43b2-8bda-74f18be7cf6c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16103-376-06	2024-01-19	Pharbetol Extra Stength Tablet
16103-376-08	2024-01-19	Pharbetol Extra Stength Tablet
16103-376-11	2024-01-19	Pharbetol Extra Stength Tablet
16103-376-06	2022-01-28	Pharbetol Extra Stength Tablet
16103-376-08	2022-01-28	Pharbetol Extra Stength Tablet
16103-376-11	2022-01-28	Pharbetol Extra Stength Tablet
16103-376-06	2020-05-22	Pharbetol Extra Stength Tablet
16103-376-08	2020-05-22	Pharbetol Extra Stength Tablet
16103-376-11	2020-05-22	Pharbetol Extra Stength Tablet
16103-376-06	2020-01-31	Pharbetol Extra Stength Tablet
16103-376-08	2020-01-31	Pharbetol Extra Stength Tablet
16103-376-11	2020-01-31	Pharbetol Extra Stength Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16103-376-06	Pharbetol	50 in 1 BOTTLE, PLASTIC	TABLET	50	5
16103-376-06	Pharbetol	1 in 1 CARTON	TABLET	1	5
16103-376-08	Pharbetol	100 in 1 BOTTLE, PLASTIC	TABLET	100	5
16103-376-08	Pharbetol	1 in 1 CARTON	TABLET	1	5
16103-376-11	Pharbetol	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-376-06	EA - Each	16103-376	b0ec28db-7535-413e-805f-e1416eeca918	1	2012-07-24
16103-376-08	EA - Each	16103-376	b9284189-e1cd-4f69-88be-fb02466b57ca	1	2012-07-24
16103-376-11	EA - Each	16103-376	7d6a6a6a-b98e-44d2-8664-e2351539d62b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-376	PHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 5 package rows	20250101_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 35 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Goodys Cool Orange Headache	ACETAMINOPHEN AND ASPIRIN AND CAFFEINE	Medtech Products Inc.	31212c97-9975-427e-bc3d-f7125f30299a	2025-10-23	Warnings	Exact identifier application number: M013
BC Arthritis	ASPIRIN AND CAFFEINE	Medtech Products Inc.	3a85be2d-6548-4de5-8109-60e1ca2bfca3	2025-10-23	Warnings	Exact identifier application number: M013
Goodys Extra Strength	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Medtech Products Inc.	d4325b17-23bc-44ac-868d-bb0886853a73	2025-10-23	Warnings	Exact identifier application number: M013
BC	ASPIRIN AND CAFFEINE	Medtech Products Inc.	226173d4-b6d5-4fe6-b24e-1cc5d1b31c88	2025-10-23	Warnings	Exact identifier application number: M013
BC MAX	ASPIRIN, ACETAMINOPHEN, CAFFEINE	Medtech Products Inc.	1e2a07ab-23e6-49b4-a676-212dc6880f14	2025-10-23	Warnings	Exact identifier application number: M013
Ecotrin Regular Strength	ASPIRIN	Medtech Products Inc.	36cb530b-25b2-4f62-a25d-aa04360815a8	2025-10-23	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	TOPCO ASSOCIATES LLC	bbc367cc-6c79-498e-8fca-1347e6ea1a8c	2025-10-22	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Rugby Laboratories	b16ed4ef-689c-4df2-ab6c-207aa8b9925d	2025-10-22	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	TIME CAP LABS INC	05364eb4-07a1-a4d9-e063-6294a90a47e5	2025-10-21	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin, Caffeine	ACETAMINOPHEN, ASPIRIN, CAFFEINE	CVS Pharmacy, Inc.	6deb854f-863e-24ad-e053-2991aa0afb17	2025-10-21	Warnings	Exact identifier application number: M013
BackAid	ACETAMINOPHEN, CAFFEINE	Kobayashi Healthcare International, Inc.	25db6bb5-96b6-4be1-e063-6294a90a2300	2025-10-21	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Method Pharmaceuticals, LLC	1539dc44-15a0-153b-e063-6294a90a9d45	2025-10-21	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Method Pharmaceuticals, LLC	3d1bb61c-15db-4eba-aba9-cfbcbc7b30e0	2025-10-21	Warnings	Exact identifier application number: M013
Walgreens Antacid Pain Relief Extra Strength	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walgreens	b60df498-07db-500b-e053-2a95a90aff6a	2025-10-17	Warnings	Exact identifier application number: M013
Equate Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walmart	6271b34b-55a0-40a8-e053-2a91aa0acb22	2025-10-17	Warnings, Adverse reactions	Exact identifier application number: M013
Xesso Neo	BENZOCAINE	PREMIUM NATURAL COSMETICS INC	163f32cd-4e51-950a-e063-6394a90a4816	2025-10-17	Warnings	Exact identifier application number: M013
Menstrual Complete Maximum Strength	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	CHAIN DRUG MARKETING ASSOCIATION INC	913d8bdb-7644-464c-b9a6-55387ff12059	2025-10-17	Warnings	Exact identifier application number: M013
Alka-Seltzer Hangover Relief	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	dc235b06-999e-221d-e053-2a95a90a0ce1	2025-10-16	Warnings	Exact identifier application number: M013
Aspirin 81mg	ASPIRIN ENTERIC COATED TABLETS 81MG	VITANE PHARMACEUTICALS, INC	41386de5-5857-efab-e063-6294a90afd9c	2025-10-15	Warnings	Exact identifier application number: M013
Aspirin 81mg	ASPIRIN ENTERIC COATED TABLETS 81MG	VITANE PHARMACEUTICALS, INC	4138d4c0-baa5-1f20-e063-6394a90a788f	2025-10-15	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	64696f65-415e-4ce1-a5b3-70662fbcb002	17
198440	acetaminophen 500 MG Oral Tablet	SCD	64696f65-415e-4ce1-a5b3-70662fbcb002	17
198440	APAP 500 MG Oral Tablet	SY	64696f65-415e-4ce1-a5b3-70662fbcb002	17
198440	acetaminophen 500 MG Oral Tablet	PSN	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	5
198440	acetaminophen 500 MG Oral Tablet	PSN	51ba690e-d76b-41c6-a083-8bc803e1faa2	5
1293942	Pharbetol 500 MG Oral Tablet	PSN	51ba690e-d76b-41c6-a083-8bc803e1faa2	5
1293942	Pharbetol 500 MG Oral Tablet	PSN	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	5
1293942	acetaminophen 500 MG Oral Tablet [Pharbetol]	SBD	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	5
1293942	acetaminophen 500 MG Oral Tablet [Pharbetol]	SBD	51ba690e-d76b-41c6-a083-8bc803e1faa2	5
198440	acetaminophen 500 MG Oral Tablet	SCD	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	5
198440	acetaminophen 500 MG Oral Tablet	SCD	51ba690e-d76b-41c6-a083-8bc803e1faa2	5
198440	APAP 500 MG Oral Tablet	SY	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	5
198440	APAP 500 MG Oral Tablet	SY	51ba690e-d76b-41c6-a083-8bc803e1faa2	5
1293942	APAP 500 MG Oral Tablet [Pharbetol]	SY	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	5
1293942	APAP 500 MG Oral Tablet [Pharbetol]	SY	51ba690e-d76b-41c6-a083-8bc803e1faa2	5
1293942	Pharbetol 500 MG Oral Tablet	SY	51ba690e-d76b-41c6-a083-8bc803e1faa2	5
1293942	Pharbetol 500 MG Oral Tablet	SY	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	5
198440	acetaminophen 500 MG Oral Tablet	PSN	19f6c2a4-9969-471b-85ef-f01c56cf92ed	2
1293942	Pharbetol 500 MG Oral Tablet	PSN	19f6c2a4-9969-471b-85ef-f01c56cf92ed	2
1293942	acetaminophen 500 MG Oral Tablet [Pharbetol]	SBD	19f6c2a4-9969-471b-85ef-f01c56cf92ed	2
198440	acetaminophen 500 MG Oral Tablet	SCD	19f6c2a4-9969-471b-85ef-f01c56cf92ed	2
198440	APAP 500 MG Oral Tablet	SY	19f6c2a4-9969-471b-85ef-f01c56cf92ed	2
1293942	APAP 500 MG Oral Tablet [Pharbetol]	SY	19f6c2a4-9969-471b-85ef-f01c56cf92ed	2
1293942	Pharbetol 500 MG Oral Tablet	SY	19f6c2a4-9969-471b-85ef-f01c56cf92ed	2
198440	acetaminophen 500 MG Oral Tablet	PSN	6a70eac1-9947-80a8-e053-2991aa0abfde	1
198440	acetaminophen 500 MG Oral Tablet	SCD	6a70eac1-9947-80a8-e053-2991aa0abfde	1
198440	APAP 500 MG Oral Tablet	SY	6a70eac1-9947-80a8-e053-2991aa0abfde	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16103-376-06	16103037606	1 BOTTLE, PLASTIC in 1 CARTON (16103-376-06) / 50 TABLET in 1 BOTTLE, PLASTIC		2006-01-10	0000-00-00	No	No	Current
16103-376-08	16103037608	1 BOTTLE, PLASTIC in 1 CARTON (16103-376-08) / 100 TABLET in 1 BOTTLE, PLASTIC		2006-01-10	0000-00-00	No	No	Current
16103-376-11	16103037611	1000 TABLET in 1 BOTTLE, PLASTIC (16103-376-11)	1000 tablet	2006-01-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen Extra Stength Tablet	PD-Rx Pharmaceuticals, Inc.	2026-01-12	HUMAN OTC DRUG LABEL	17
Pharbetol Extra Stength Tablet	Pharbest Pharmaceuticals, Inc.	2025-12-24	HUMAN OTC DRUG LABEL	5
Drug Facts	Proficient Rx LP	2024-02-01	HUMAN OTC DRUG LABEL	4
Drug Facts	Proficient Rx LP	2024-01-01	HUMAN OTC DRUG LABEL	5
Drug Facts	A-S Medication Solutions	2023-02-04	HUMAN OTC DRUG LABEL	20
Drug Facts	ATLANTIC BIOLOGICALS CORP. \| UNIT DOSE SOLUTIONS	2022-09-08	HUMAN OTC DRUG LABEL	2
PHARBETOL	Direct_Rx	2019-07-30	HUMAN OTC DRUG LABEL	1
Drug Facts	Preferred Pharmaceuticals, Inc.	2018-05-22	HUMAN OTC DRUG LABEL	3
Acetaminophen ES - Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2018-04-22	HUMAN OTC DRUG LABEL	1