FDA.reportPublic FDA data

LITTLE REMEDIES NEW BABY ESSENTIALS

Product NDC
63029-615
Requested package NDC
63029-615-01
11-digit product format
630290615
Labeler code
63029
Product ID
63029-615_e64d548a-a9e1-430b-9091-628e8db105dc
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, SIMETHICONE, ZINC OXIDE
Dosage form
KIT
Labeler
Medtech Products Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-02-15
NDC exclude flag
No
Listing certified through
2026-12-31
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
LITTLE REMEDIES NEW BABY ESSENTIALS
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198857Internal RxNorm lookup
307675Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b1b7294-aca6-45fa-a008-c1869131b2a3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-615-01LITTLE REMEDIES NEW BABY ESSENTIALS1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-615LITTLE REMEDIES NEW BABY ESSENTIALS (ACETAMINOPHEN, SIMETHICONE, ZINC OXIDE) KIT [MEDTECH PRODUCTS INC.]2Current NDC, Legacy NDC, 1 package rows20241207_4b1b7294-aca6-45fa-a008-c1869131b2a3.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LITTLE REMEDIES NEW BABY ESSENTIALSACETAMINOPHEN, SIMETHICONE, ZINC OXIDEMedtech Products Inc.4b1b7294-aca6-45fa-a008-c1869131b2a32024-12-06WarningsExact identifier
ndc (package): 63029-615-01
ndc (product): 63029-615
ndc11 (package): 63029061501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN4b1b7294-aca6-45fa-a008-c1869131b2a32
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN4b1b7294-aca6-45fa-a008-c1869131b2a32
307675acetaminophen 32 MG/ML Oral SolutionSCD4b1b7294-aca6-45fa-a008-c1869131b2a32
198857simethicone 66.7 MG/ML Oral SuspensionSCD4b1b7294-aca6-45fa-a008-c1869131b2a32
307675acetaminophen 160 MG per 5 ML Oral SolutionSY4b1b7294-aca6-45fa-a008-c1869131b2a32
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY4b1b7294-aca6-45fa-a008-c1869131b2a32
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY4b1b7294-aca6-45fa-a008-c1869131b2a32
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY4b1b7294-aca6-45fa-a008-c1869131b2a32
307675APAP 32 MG/ML Oral SolutionSY4b1b7294-aca6-45fa-a008-c1869131b2a32
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY4b1b7294-aca6-45fa-a008-c1869131b2a32
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY4b1b7294-aca6-45fa-a008-c1869131b2a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-615-01630290615011 KIT in 1 CARTON (63029-615-01) * 57 g in 1 TUBE * 59 mL in 1 BOTTLE * 15 mL in 1 BOTTLE * 30 mL in 1 BOTTLE * 59 mL in 1 BOTTLE1 kit2017-02-150000-00-00NoNoCurrent