Diabetic Tussin Nighttime Cold and Flu

Product NDC: 61787-452
11-digit product format: 617870452
Labeler code: 61787
Product ID: 61787-452_2754aad5-00ec-4788-9efd-2d0c774804d8
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Health Care Products
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-08-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 325 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61787-452		I	Inactivated by FDA	2026-10-21
excluded package	package	61787-452	61787-452-04	I	Inactivated by FDA	2026-10-21
excluded package	package	61787-452	61787-452-08	I	Inactivated by FDA	2026-10-21

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 · 57 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61787-452-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61787-452-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61787-452-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61787-452-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61787-452-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61787-452-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61787-452-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61787-452-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61787-452-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61787-452-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61787-452-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61787-452-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61787-452-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61787-452-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61787-452-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61787-452-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61787-452-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61787-452-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61787-452-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61787-452-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61787-452-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61787-452-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61787-452-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61787-452-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61787-452-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61787-452-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61787-452-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61787-452-08	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61787-452-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61787-452-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61787-452-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61787-452-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61787-452-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61787-452-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61787-452-08	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61787-452-04	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61787-452-08	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61787-452-04	`8dfbde2a14a4…`	`c9ff85d89658…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61787-452-04	2021-01-29	C162847	48780-1	ba0f9c33-5d66-a910-e053-dadaa90a0b85	Drug Facts
61787-452-08	2021-01-29	C162847	48780-1	ba0f9c33-5d66-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61787-452-04	Diabetic Tussin Nighttime Cold and Flu	1 in 1 CARTON	LIQUID	1	3
61787-452-04	Diabetic Tussin Nighttime Cold and Flu	118 mL in 1 BOTTLE	LIQUID	118	3
61787-452-08	Diabetic Tussin Nighttime Cold and Flu	237 mL in 1 BOTTLE	LIQUID	237	3
61787-452-08	Diabetic Tussin Nighttime Cold and Flu	1 in 1 CARTON	LIQUID	1	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61787-452-08	ML - Milliliter	61787-452	e6bfcca0-539a-44b3-a276-31cb70817257	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61787-452	DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [HEALTH CARE PRODUCTS]	3	Legacy NDC, 4 package rows	20191221_96ef6c88-ce06-4d7a-ab7b-42af64ba3149.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094131	acetaminophen 325 MG / dextromethorphan HBr 10 MG / diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	96ef6c88-ce06-4d7a-ab7b-42af64ba3149	3
1094131	acetaminophen 65 MG/ML / dextromethorphan hydrobromide 2 MG/ML / diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	96ef6c88-ce06-4d7a-ab7b-42af64ba3149	3
1094131	APAP 325 MG / dextromethorphan hydrobromide 10 MG / diphenhydramine hydrochloride 12.5 MG per 5 ML Oral Solution	SY	96ef6c88-ce06-4d7a-ab7b-42af64ba3149	3
1094131	APAP 65 MG/ML / Dextromethorphan Hydrobromide 2 MG/ML / Diphenhydramine Hydrochloride 2.5 MG/ML Oral Solution	SY	96ef6c88-ce06-4d7a-ab7b-42af64ba3149	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
61787-452-04	61787045204	1 in 1 CARTON		Historical
61787-452-08	61787045208	237 mL in 1 BOTTLE	237 ml	Historical