Allergy Relief

Product NDC: 72090-021
Requested package NDC: 72090-021-26
11-digit product format: 720900021
Labeler code: 72090
Product ID: 72090-021_73414302-0de0-4cb0-9f6d-243b0345a166
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl 25 mg
Dosage form: TABLET
Route: ORAL
Labeler: Pioneer Life Sciences, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-29
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	72090-021	72090-021-26	I	Inactivated by FDA		2026-10-15

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 · 18 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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: Allergy Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	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
ab45ae97-7951-4058-e053-2995a90a7b2e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
72090-021-10	2024-05-13	d6a99b39-de89-a426-e053-dadaa90af4c2	ab45ed16-86bb-3faf-e053-2995a90acfbc
72090-021-60	2023-10-25	d6a99b39-ac04-a426-e053-dadaa90af4c2	ab45ae97-7951-4058-e053-2995a90a7b2e
72090-021-10	2022-01-28	d6a99b39-de89-a426-e053-dadaa90af4c2	ab45ed16-86bb-3faf-e053-2995a90acfbc
72090-021-24	2022-01-28	d6a99b39-8fca-a426-e053-dadaa90af4c2	a824b04e-1654-28f4-e053-2a95a90ab8bb
72090-021-26	2022-01-28	d6a99b39-418b-a426-e053-dadaa90af4c2	a96484ba-c618-ee52-e053-2a95a90a3344
72090-021-60	2022-01-28	d6a99b39-ac04-a426-e053-dadaa90af4c2	ab45ae97-7951-4058-e053-2995a90a7b2e
72090-021-25	2021-01-29	ba0f9c33-1a66-a910-e053-dadaa90a0b85	Diphenhydramine HCl 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72090-021-60	Allergy Relief	600 in 1 BOTTLE	TABLET	600	6
72090-021-10	Allergy Relief	1000 in 1 BOTTLE	TABLET	1000	3
72090-021-24	Allergy Relief	24 in 1 BOTTLE	TABLET	24	1
72090-021-25	Allergy Relief	250 in 1 BOTTLE	TABLET	250	1
72090-021-26	Allergy Relief	1 in 1 CARTON	TABLET	1	1
72090-021-26	Allergy Relief	24 in 1 BOTTLE	TABLET	24	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72090-021	ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20240522_ab45ae97-7951-4058-e053-2995a90a7b2e.zip
72090-021	ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20240514_ab45ed16-86bb-3faf-e053-2995a90acfbc.zip
72090-021	ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20190220_7c1a38de-555f-46e6-91c5-2d14aa9ab5d1.zip
72090-021	ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20200702_a96484ba-c618-ee52-e053-2a95a90a3344.zip
72090-021	ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20200629_a824b04e-1654-28f4-e053-2a95a90ab8bb.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 7 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS PHARMACY	3148f80f-8a0d-4b6c-85be-79085fc04444	2026-08-19	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	aa7164a7-f842-457d-abee-0740bb8c1c90	2026-08-19	Warnings	Exact identifier application number: M012
CVS	CHILDRENS STUFFY NOSE AND COLD	CVS PHARMACY, INC	6cff265d-94a3-4617-a366-fe970d97f05a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Congestion and Pain Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS	5a8e4320-bae1-4831-b66b-9babfe8888d6	2026-08-19	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	CVS PHARMACY	0ae0c244-e019-4b35-890c-8e15e3d3f7ce	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	e32881f5-2bb5-4756-aa86-a09473ab590b	2026-08-19	Warnings	Exact identifier application number: M012
Good Sense Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	L. Perrigo Company	d2541ef0-a73c-43aa-91ff-fdbce2748c4f	2026-08-18	Warnings	Exact identifier application number: M012
CVS Severe Nasal Congestion Relief Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	5a7e42ee-810c-4bc1-9d8d-fac8e849e126	2026-08-18	Warnings	Exact identifier application number: M012
DAYTIME NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	8dd039b4-209a-484a-b15e-741d55087a93	2026-08-18	Warnings	Exact identifier application number: M012
CVS Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	CVS PHARMACY	558b7ed6-a9f6-452c-90cd-df8258663bf1	2026-08-18	Warnings	Exact identifier application number: M012
Extra Strength Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	7acf1a9a-bd97-48bb-8025-ac26070378a2	2026-08-18	Warnings	Exact identifier application number: M012
Polytussin DM	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE	Poly Pharmaceuticals, Inc.	fda8f594-82bf-1781-e053-6294a90ad344	2026-08-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	da1f1ef9-a974-4998-8e1d-c1d999596943	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	89168715-71b1-424e-8dae-fcfa90bc85bf	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Sinus	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	c7840511-3a4f-4547-ae90-19b085a5874e	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health	NASAL OXYMETAZOLINE HCL	CVS Pharmacy,Inc.	56f08e70-bf16-4933-97bc-177bc190d12a	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health No Drip	ALLERGY NASAL	CVS PHARMACY,INC.	3e76ffac-07a7-4b6a-bc4c-9cabb653e064	2026-08-17	Warnings	Exact identifier application number: M012
CVS dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	2026-08-17	Warnings	Exact identifier application number: M012
CVS Overnight Cold and Flu Clear and Cool	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	CVS PHARMACY, INC	2497a011-d7a0-4d69-97e2-bbf25a99b1cc	2026-08-17	Warnings	Exact identifier application number: M012
Mucus Relief Cough Cold Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	3ef949f5-ac8c-44be-b04d-6996fa59a94b	2026-08-17	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	ab45ae97-7951-4058-e053-2995a90a7b2e	6
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	ab45ae97-7951-4058-e053-2995a90a7b2e	6
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	ab45ed16-86bb-3faf-e053-2995a90acfbc	3
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	ab45ed16-86bb-3faf-e053-2995a90acfbc	3
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	7c1a38de-555f-46e6-91c5-2d14aa9ab5d1	1
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	a824b04e-1654-28f4-e053-2a95a90ab8bb	1
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	a96484ba-c618-ee52-e053-2a95a90a3344	1
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	7c1a38de-555f-46e6-91c5-2d14aa9ab5d1	1
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	a824b04e-1654-28f4-e053-2a95a90ab8bb	1
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	a96484ba-c618-ee52-e053-2a95a90a3344	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72090-021-26	72090002126	1 BOTTLE in 1 CARTON (72090-021-26) > 24 TABLET in 1 BOTTLE	1 bottle	2020-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allergy Relief - Pioneer Life Sciences, LLC	Pioneer Life Sciences, LLC	2025-12-23	HUMAN OTC DRUG LABEL	6
Allergy Relief - Pioneer Life Sciences, LLC	Pioneer Life Sciences, LLC	2025-12-23	HUMAN OTC DRUG LABEL	3
Allergy Relief - Pioneer Life Sciences, LLC	Pioneer Life Sciences, LLC	2020-07-01	HUMAN OTC DRUG LABEL	1
Allergy Relief - Pioneer Life Sciences, LLC	Pioneer Life Sciences, LLC	2020-06-15	HUMAN OTC DRUG LABEL	1
Diphenhydramine HCl 25 mg	Pioneer Life Sciences, LLC	2018-10-01	HUMAN OTC DRUG LABEL	1