Maximum Allergy Relief

Product NDC: 81238-0240
Requested package NDC: 81238-0240-2
11-digit product format: 812380240
Labeler code: 81238
Product ID: 81238-0240_6e3cc529-336b-4c7c-a635-0fdbf5f14967
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, PHENYLEPHRINE HCl
Dosage form: TABLET
Route: ORAL
Labeler: Western First Aid Safety DBA Aramark
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-05-07
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 500 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	81238-0240	81238-0240-2	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81238-0240-1	2023-01-30	C162847	48780-1	f386c64a-3ef5-0266-e053-dadaa90a7c1a	Aramark Maximum Allergy Relief
81238-0240-2	2023-01-30	C162847	48780-1	f386c64a-3ef5-0266-e053-dadaa90a7c1a	Aramark Maximum Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81238-0240-1	Maximum Allergy Relief	50 in 1 BOX	TABLET	50	1
81238-0240-1	Maximum Allergy Relief	2 in 1 PACKET	TABLET	2	1
81238-0240-2	Maximum Allergy Relief	125 in 1 BOX	TABLET	125	1
81238-0240-2	Maximum Allergy Relief	2 in 1 PACKET	TABLET	2	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81238-0240	MAXIMUM ALLERGY RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WESTERN FIRST AID SAFETY DBA ARAMARK]	1	Legacy NDC, 4 package rows	20210613_cabd4342-7957-42ad-baa3-1f6c512cdf8c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1101534	acetaminophen 500 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	cabd4342-7957-42ad-baa3-1f6c512cdf8c	1
1101534	acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	cabd4342-7957-42ad-baa3-1f6c512cdf8c	1
1101534	APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	cabd4342-7957-42ad-baa3-1f6c512cdf8c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81238-0240-2	81238024002	125 PACKET in 1 BOX (81238-0240-2) > 2 TABLET in 1 PACKET	125 packet	2021-05-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aramark Maximum Allergy Relief	Western First Aid Safety DBA Aramark \| ULTRA SEAL CORPORATION	2021-06-11	HUMAN OTC DRUG LABEL	1