Allergy Relief

Product NDC: 70677-1014
11-digit product format: 706771014
Labeler code: 70677
Product ID: 70677-1014_b8537f79-1f0c-42e4-b010-78f9d1821488
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-03-28
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: 2027-12-31
Current FDA listing: Yes

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: 2027-12-31

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
ba6d69ff-b392-4f21-b3d7-00d8ec5dee32	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
70677-1014-1	Allergy Relief	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	7
70677-1014-1	Allergy Relief	2 in 1 CARTON	TABLET, FILM COATED	2	7
70677-1014-2	Allergy Relief	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	7
70677-1014-2	Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-1014-1	EA - Each	70677-1014	1b63eb0a-4d51-42ed-9c46-9791ecc4cbbf	1	2023-09-05
70677-1014-2	EA - Each	70677-1014	1905fa9d-c311-4ae2-817a-73f994207260	1	2026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-1014	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]	5	Current NDC, 4 package rows	20240925_ba6d69ff-b392-4f21-b3d7-00d8ec5dee32.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 144 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tussin severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	7cc2c136-d1b7-4658-99bb-73bb1d140261	2024-11-04	Warnings	Exact identifier application number: M012
dg health tussin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	a5d0ee70-d528-4a53-bf01-7bb13b364ed0	2024-11-04	Warnings	Exact identifier application number: M012
basic care tussin cf severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	bba9a17d-eb87-46f3-acee-c9dd34e5bfd4	2024-11-04	Warnings	Exact identifier application number: M012
topcare tussin cf max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	b553b7e6-933b-49e3-97d3-22a4643a04b9	2024-11-04	Warnings	Exact identifier application number: M012
dg health nasal original	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	fb209752-705a-4bb0-9298-8b70357f3911	2024-11-02	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	3c301993-642a-487c-96a2-ebc4ef90dc88	2024-11-02	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	1341744c-43c3-462b-b93c-1e46476fd935	2024-11-01	Warnings	Exact identifier application number: M012
Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	43784616-1afd-4ff7-8fee-6ac389f616a2	2024-11-01	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	28ef87e8-29e5-444d-b1f7-5c38a7f758d3	2024-11-01	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	0e3c36c9-d45b-41b9-891d-a42d854295f9	2024-11-01	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	7dc3941a-e5f8-4caa-bae5-6a0d075295cb	2024-11-01	Warnings	Exact identifier application number: M012
DoloMax Cold Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	BENARD INDUSTRIES INC	520aee75-8b9a-4dcc-8970-75e122640e91	2024-10-31	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe	2024-10-31	Warnings	Exact identifier application number: M012
CareOne Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	American Sales Company	819d5c82-0240-4013-9904-c335bd65d03e	2024-10-30	Warnings	Exact identifier application number: M012
Signature Care Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway	9a0ad5d5-8fd9-468d-be2c-87c14d08b934	2024-10-30	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2	2024-10-30	Warnings	Exact identifier application number: M012
dg health cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp, LLC	81f3ac36-9bae-4f42-92a0-8a2e4bbd0984	2024-10-30	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Rite Aid Corporation	9a71e8eb-4195-4694-bf3e-44f691ff2cef	2024-10-30	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	H E B	fe4a95d2-6fb3-43fe-baec-6f22d1965323	2024-10-30	Warnings	Exact identifier application number: M012
NightTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger Company	2c9ef0d7-3d5b-494a-8f06-9dd42110d78a	2024-10-30	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	ba6d69ff-b392-4f21-b3d7-00d8ec5dee32	7
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	ba6d69ff-b392-4f21-b3d7-00d8ec5dee32	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70677-1014-1	70677101401	2 BLISTER PACK in 1 CARTON (70677-1014-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2023-03-28	No	No	Current
70677-1014-2	70677101402	1 BOTTLE, PLASTIC in 1 CARTON (70677-1014-2) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2026-03-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Foster and Thrive 44-329	Strategic Sourcing Services LLC \| LNK International, Inc.	2026-03-11	HUMAN OTC DRUG LABEL	7