Allergy Relief

Product NDC: 36800-909
11-digit product format: 368000909
Labeler code: 36800
Product ID: 36800-909_2850dd0b-fd81-c211-e063-6394a90a77ca
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: TopCo Associates LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-08-30
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-909	36800-909-03	D	Discontinued by firm		2026-10-16
excluded package	package	36800-909	36800-909-05	D	Discontinued by firm		2026-10-16

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	36800-909-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-909-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-909-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-909-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-909-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-909-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-909-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-909-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-909-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-909-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-909-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-909-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-909-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-909-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-909-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-909-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-909-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-909-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-909-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-909-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-909-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-909-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-909-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-909-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
53b15e75-9efd-4b4b-834b-6e9f12c60108	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-909-01	Allergy Relief	12 in 1 BLISTER PACK	TABLET, COATED	12	5
36800-909-01	Allergy Relief	2 in 1 CARTON	TABLET, COATED	2	5
36800-909-02	Allergy Relief	4 in 1 CARTON	TABLET, COATED	4	5
36800-909-02	Allergy Relief	12 in 1 BLISTER PACK	TABLET, COATED	12	5
36800-909-03	Allergy Relief	1 in 1 CARTON	TABLET, COATED	1	5
36800-909-03	Allergy Relief	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	5
36800-909-05	Allergy Relief	400 in 1 BOTTLE, PLASTIC	TABLET, COATED	400	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-909-01	EA - Each	36800-909	0a0b94e7-74d1-4413-b0c7-9f76fa35d5f9	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-909	ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TOPCO ASSOCIATES LLC]	5	Current NDC, Legacy NDC, 7 package rows	20241204_53b15e75-9efd-4b4b-834b-6e9f12c60108.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 6 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HyVee Daytime Severe Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	496ec389-1aea-f202-e063-6394a90ae51c	2026-08-20	Warnings	Exact identifier application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	4d94968b-ada3-4344-8563-cba7fc491d74	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Mucus chest congestion	GUAIFENESIN	CVS PHARMACY	bec04049-03b2-4465-9cf5-0ad2ef8014ef	2026-08-19	Warnings	Exact identifier application number: M012
CVS Childrens Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	CVS PHARMACY, INC	fe12f3bd-3237-42d1-aec5-c831b9637175	2026-08-19	Warnings	Exact identifier application number: M012
CVS Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9	2026-08-19	Warnings	Exact identifier application number: M012
CVS Long Acting Cough	DEXTROMETHORPHAN HBR	CVS PHARMACY, INC	31a7c0e2-af1c-45dd-8a93-e0879cae6005	2026-08-19	Warnings	Exact identifier application number: M012
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	b3baf939-a9fd-47ac-9bc7-68435e32ea1e	2026-08-19	Warnings	Exact identifier application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS PHARMACY	5151127a-4d09-413a-a08b-f76fb77e1188	2026-08-19	Warnings	Exact identifier application number: M012
CVS DT and NT Combo Pack Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS PHARMACY	360c8c62-0945-4031-b291-d40c4270b940	2026-08-19	Warnings	Exact identifier application number: M012
equate childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	WALMART INC.	24758ab0-ba08-4b4a-9861-449612bdb89c	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Mucus plus Chest Congestion	GUAIFENESIN	CVS PHARMACY	3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Childrens Cold plus Cough plus Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	CVS	7dc30e46-e289-40fc-b217-b123fee5daee	2026-08-19	Warnings	Exact identifier application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	CVS PHARMACY	4490a7e1-d5b9-459c-8751-c24486807981	2026-08-19	Warnings	Exact identifier application number: M012
CVS DayTime and NightTime Value Pack Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS PHARMACY	4c813cd5-2c97-4fc3-926c-1a0396551a31	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Cough plus Chest Congestion DM Max with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS PHARMACY	822d5bf6-8841-4b7f-bbf7-90c3d50b8024	2026-08-19	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	2517b241-c433-440f-999d-5a32d5bbaa26	2026-08-19	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cough and Chest Congestion Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	CVS Pharmacy	347f1731-5b85-4220-ae2b-9497a3afa4ed	2026-08-19	Warnings	Exact identifier application number: M012
CVS Maximum Strength Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL	CVS PHARMACY	e1c246a4-7a8c-4761-ab26-13b5165029cc	2026-08-19	Warnings	Exact identifier application number: M012
CVS childrens Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR	CVS PHARMACY	035c5e2a-04e3-490b-8f1a-233a5cb6eadb	2026-08-19	Warnings	Exact identifier application number: M012
rugby cough syrup	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rugby Laboratories	89752c69-25c8-45e3-9021-f81b35b52d36	2026-08-19	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	53b15e75-9efd-4b4b-834b-6e9f12c60108	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	53b15e75-9efd-4b4b-834b-6e9f12c60108	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-909-01	36800090901	2 BLISTER PACK in 1 CARTON (36800-909-01) / 12 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2011-08-30	0000-00-00	No	No	Current
36800-909-02	36800090902	4 BLISTER PACK in 1 CARTON (36800-909-02) / 12 TABLET, COATED in 1 BLISTER PACK	4 blister pack	2011-08-30	0000-00-00	No	No	Current
36800-909-03	36800090903	1 BOTTLE, PLASTIC in 1 CARTON (36800-909-03) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC		2011-08-30	0000-00-00	No	No	Current
36800-909-05	36800090905	400 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-909-05)		2011-08-30	0000-00-00	No	No	Current