Head and Cold

Product NDC: 69732-003
Requested package NDC: 69732-003-01
11-digit product format: 697320003
Labeler code: 69732
Product ID: 69732-003_4e541679-127c-5194-e063-6294a90a4e42
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, guaifenesin, dextromethorphan HBr, phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Hi-Tech Nutraceuticals, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-04-30
Substance: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 325; 5; 10; 200 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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.

Additional Listing Data#

Finished product: Yes
Brand name base: Head and Cold
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
GUAIFENESIN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1110988	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
a39c772b-3cce-14cb-e053-2a95a90a733b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69732-003-01	2024-01-30	C162847	48780-1	1030e365-0c5f-111a-e063-dadaa90a10e2	Head and Cold

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69732-003-01	Head and Cold	30 in 1 BOTTLE, PLASTIC	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69732-003	HEAD AND COLD (ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [HI-TECH NUTRACEUTICALS, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20230101_a39c772b-3cce-14cb-e053-2a95a90a733b.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 22 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive daytime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a6	2026-06-16	Warnings	Exact identifier application number: M012
Equate Severe Cold Cough and Flu	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	a35531d7-1a96-45cb-922f-61db085cde1f	2026-06-16	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	5fe9f313-d6e7-41f5-abfc-e4c72b708961	2026-06-15	Warnings	Exact identifier application number: M012
Pain Relief Sinus Congestion	ACETAMINOPHEN, PHENYLEPHRINE HCL	Better Living Brands, LLC	1d3d6397-0d92-4145-9a70-8bcc45bd0322	2026-06-15	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11	2026-06-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	d5d9334d-3db6-4f45-ab84-3e1ec5a752c6	2026-06-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Geiss, Destin & Dunn Inc.	fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b	2026-06-15	Warnings	Exact identifier application number: M012
equate daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	983a4783-d826-41b6-8087-ca66bcd5b6ca	2026-06-12	Warnings	Exact identifier application number: M012
Equate Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	4173ecde-a2d7-4836-a6e9-fef2270d1b4e	2026-06-12	Warnings	Exact identifier application number: M012
PAIN RELIEVER PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Best Choice (Valu Merchandisers Company)	cf370a59-42d5-42fe-882f-09885c55f570	2026-06-11	Warnings	Exact identifier application number: M012
Sudafed Sinus Congestion Plus Cold Severe Day	ACETAMINOPHEN, PSEUDOEPHEDRINE	Kenvue Brands LLC	537e1a0d-820d-c3f7-e063-6294a90a56ea	2026-06-10	Warnings	Exact identifier application number: M012
Sudafed Sinus Congestion plus Cold Severe Day and Night	ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE	Kenvue Brands LLC	5382dcad-0337-4440-e063-6394a90a706e	2026-06-10	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	21cfa71c-7a8f-4100-a42e-9190260653d1	2026-06-09	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL	WALGREENS	47f1d92f-cb4b-1635-e063-6294a90a2c71	2026-06-09	Warnings	Exact identifier application number: M012
HALLS Honey	MENTHOL	Mondelez Global LLC	837f5ded-8efb-402b-a1bc-b5c142755660	2026-06-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution Inc	932b11b1-f4a0-417a-bfa1-05261a172155	2026-06-08	Warnings	Exact identifier application number: M012
NO DRIP NASAL MIST	OXYMETAZOLINE HYDROCHLORIDE	Kroger Company	957efbcf-b6d3-4793-bb6e-27e99c9be905	2026-06-08	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	493caecb-e687-49ea-b7a1-2a5b9376896d	2026-06-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	4ad10fd7-c088-4356-9d34-a95cfe3a4133	2026-06-08	Warnings	Exact identifier application number: M012
Theraflu Severe Congestion Relief Nasal Mist	OXYMETAZOLINE HCL	Haleon US Holdings LLC	4ec42064-7390-4137-a93e-57343c3c76a7	2026-06-08	Warnings	Exact identifier application number: M012

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
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1110988	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	a39c772b-3cce-14cb-e053-2a95a90a733b	4
1110988	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	a39c772b-3cce-14cb-e053-2a95a90a733b	4
1110988	APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	a39c772b-3cce-14cb-e053-2a95a90a733b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69732-003-01	69732000301	30 TABLET in 1 BOTTLE, PLASTIC (69732-003-01)	30 tablet	2020-04-30	0000-00-00	No	No	Current