COLDTAC Plus
- Product NDC
- 69729-143
- 11-digit product format
- 697290143
- Labeler code
- 69729
- Product ID
- 69729-143_574a9f60-3b83-0bc7-e063-6294a90a5482
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Phenylephrin Hydrochloride, Dextromethorphan Hydrobromide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-01-05
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 325; 5; 15; 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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 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 | 69729-143-06 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 69729-143-72 | 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 | 69729-143-06 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 69729-143-72 | 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 | 69729-143-06 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 69729-143-72 | 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 | 69729-143-06 | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 69729-143-72 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69729-143-06 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69729-143-72 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69729-143-06 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69729-143-72 | 9bebd1f3094a… | 5416666fcb17… |
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
- COLDTAC Plus
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| GUAIFENESIN | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1367204 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3496866c-682f-420b-bfdb-64ecebbf70a2 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 69729-143-06 | 2022-10-20 | COLDTAC Plus |
| 69729-143-06 | 2022-10-20 | COLDTAC Plus |
| 69729-143-72 | 2022-10-20 | COLDTAC Plus |
| 69729-143-72 | 2022-10-20 | COLDTAC Plus |
| 69729-143-06 | 2020-01-31 | COLDTAC Plus |
| 69729-143-06 | 2020-01-31 | COLDTAC Plus |
| 69729-143-72 | 2020-01-31 | COLDTAC Plus |
| 69729-143-72 | 2020-01-31 | COLDTAC Plus |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-143-02 | COLDTAC Plus | 2 in 1 POUCH | TABLET | 2 | 7 | |
| 69729-143-06 | COLDTAC Plus | 6 in 1 PACKAGE | TABLET | 6 | 7 | |
| 69729-143-72 | COLDTAC Plus | 72 in 1 PACKAGE | TABLET | 72 | 7 |
DailyMed Dashboard NDC Coverage#
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.
| 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 | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | aa7164a7-f842-457d-abee-0740bb8c1c90 | 2026-08-19 | Warnings | M012 |
| CVS | CHILDRENS STUFFY NOSE AND COLD | CVS PHARMACY, INC | 6cff265d-94a3-4617-a366-fe970d97f05a | 2026-08-19 | Warnings | M012 |
| CVS Severe Congestion and Pain Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS | 5a8e4320-bae1-4831-b66b-9babfe8888d6 | 2026-08-19 | Warnings | M012 |
| CVS Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | CVS PHARMACY | 0ae0c244-e019-4b35-890c-8e15e3d3f7ce | 2026-08-19 | Warnings | M012 |
| CVS Severe Tussin CF Max | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | e32881f5-2bb5-4756-aa86-a09473ab590b | 2026-08-19 | Warnings | M012 |
| Good Sense Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | L. Perrigo Company | d2541ef0-a73c-43aa-91ff-fdbce2748c4f | 2026-08-18 | Warnings | M012 |
| CVS Severe Nasal Congestion Relief Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | 5a7e42ee-810c-4bc1-9d8d-fac8e849e126 | 2026-08-18 | Warnings | 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 | M012 |
| CVS Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | CVS PHARMACY | 558b7ed6-a9f6-452c-90cd-df8258663bf1 | 2026-08-18 | Warnings | M012 |
| Extra Strength Nasal | PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | 7acf1a9a-bd97-48bb-8025-ac26070378a2 | 2026-08-18 | Warnings | M012 |
| Polytussin DM | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE | Poly Pharmaceuticals, Inc. | fda8f594-82bf-1781-e053-6294a90ad344 | 2026-08-18 | Warnings | 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 | M012 |
| CVS Health Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | 89168715-71b1-424e-8dae-fcfa90bc85bf | 2026-08-18 | Warnings | M012 |
| CVS Health Sinus | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | c7840511-3a4f-4547-ae90-19b085a5874e | 2026-08-17 | Warnings | M012 |
| CVS Health | NASAL OXYMETAZOLINE HCL | CVS Pharmacy,Inc. | 56f08e70-bf16-4933-97bc-177bc190d12a | 2026-08-17 | Warnings | M012 |
| CVS Health No Drip | ALLERGY NASAL | CVS PHARMACY,INC. | 3e76ffac-07a7-4b6a-bc4c-9cabb653e064 | 2026-08-17 | Warnings | M012 |
| CVS dye-free childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY | db5a5eff-1bb1-4d00-8c01-caae7a1c7223 | 2026-08-17 | Warnings | 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 | 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 | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1367204 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 3496866c-682f-420b-bfdb-64ecebbf70a2 | 7 |
| 1367204 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 3496866c-682f-420b-bfdb-64ecebbf70a2 | 7 |
| 1367204 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 3496866c-682f-420b-bfdb-64ecebbf70a2 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69729-143-02 | 69729014302 | 2 in 1 POUCH | Historical | |||||
| 69729-143-06 | 69729014306 | 6 POUCH in 1 PACKAGE (69729-143-06) / 2 TABLET in 1 POUCH | 6 pouch | 2018-01-05 | 0000-00-00 | No | No | Current |
| 69729-143-50 | 69729014350 | 50 POUCH in 1 CARTON (69729-143-50) / 2 TABLET in 1 POUCH | 50 pouch | 2026-07-23 | No | No | Current | |
| 69729-143-72 | 69729014372 | 72 POUCH in 1 PACKAGE (69729-143-72) / 2 TABLET in 1 POUCH | 72 pouch | 2018-01-05 | 0000-00-00 | No | No | Current |